Body fluid sampling element

ABSTRACT

A sampling element ( 110 ) for generating a sample of a body fluid is disclosed. The sampling element ( 110 ) comprises a housing ( 114 ), the) housing having a chamber ( 122 ) with at least one puncture element ( 112 ) stored therein. A tip ( 132 ) of the puncture element ( 112 ) is movable through at least one puncture opening ( 124 ) of the housing ( 114 ) in order to perforate a skin portion of a user. The sampling element ( 110 ) further comprises at least one compression element ( 150 ), which is adapted to increase a pressure of the body fluid within a body tissue of the user in a region of puncturing when pressed onto the skin portion of the user. The compression element ( 150 ) is movably mounted to the housing ( 114 ). The sampling element ( 110 ) comprises at least one locking mechanism ( 168 ) for releasably locking the compression element ( 150 ) in at least two positions. The at least two positions comprise a first position ( 170 ) and a second position ( 172 ), the second position ( 172 ) being offset from the first position ( 170 ). In a further aspect of the invention, an analytical device ( 204 ) is disclosed, the analytical device ( 204 ) being adapted for using the sampling element ( 110 ) of the invention.

FIELD OF THE INVENTION

The invention refers to a sampling element for generating a sample of abody fluid. The sampling element preferably is adapted to provide aprotection against reuse. The invention further relates to an analyticaldevice being adapted for using the sampling element. The inventionfurther relates to a method of generating a sample of a body fluid andto a use of a position of a compression element movably mounted to ahousing of a sample element for indicating a used or unused state of thesampling element, for preventing reuse of the sampling element. Thesampling element, the method and the use according to the presentinvention preferably may be used in the field of determining thepresence and/or the concentration of one or more analytes in a bodyfluid such as blood, interstitial fluid or other types of body fluids.As an example, the at least one analyte may be one or more of glucose,cholesterol, lactate and triglyceride. Additionally or alternatively,however, other types of analytes may be determined. The invention may beapplied both in the field of home monitoring and in the field ofprofessional diagnostics such as in hospitals and/or intensive careinstitutions. Specifically, the method may be applied in the field ofself-monitoring by a user or patient or by a medical assistant and maybe performed without medical expert knowledge. In the following, withoutintending to restrict the scope of the present invention and withoutrestricting the application of the invention in other fields, theinvention will mainly be disclosed in the context of determining aconcentration of glucose in blood and/or interstitial fluid.

RELATED ART

In the art of medical diagnostics, a large number of sampling elementsfor generating and, optionally, analyzing one or more samples of a bodyfluid are known, both for home monitoring and for professional care.Thus, as an example, EP 1 669 028 A1 discloses a lancing device forgenerating an incision in a body surface. The device comprises a housingcontaining a lancet, a driving rotor and a lancet coupling mechanism.Further, a specific driving cycle is disclosed. In addition, furtherexamples of sampling elements are disclosed in WO 2011/014260 A1, EP 1586 270 A2, WO 2009/145920 A1, WO 2010/056869 A2, and WO 97/43962 A1.

For hygienic purposes, in many cases, a protection against reuse of thesampling elements is desirable. Thus, sampling elements are known whichprovide appropriate mechanisms preventing reuse. As an example, EP 1 808128 A1 discloses a puncture aid having a blocking element which isdesigned to prevent a reuse by preventing specific rotational motions ofthe puncture aid. EP 1 459 683 A1 discloses a lancet system having aprotection against reuse, the lancet system comprising a needle bodywhich protects a needle tip and provides a protection against reuse ofthe lancet system.

Further, in the art, a plurality of sampling systems are known which areadapted to automatically take a sample of a body fluid and, further, toprovide an analytical aid for detection of one or more contents withinthe sample, such as a glucose content. These combined analytical aids,containing puncture elements and means for detecting at least oneanalyte, are known in various ways. Thus, devices and systems are knowncontaining magazines having a plurality of coherent analytical aids inone housing, and single analytical aids which may be handledindependently from each other.

Thus, generally, WO 2011/044971 A2 discloses a device for taking andanalyzing a blood sample, comprising an integrated drive unit having atwo drive sources and a driving force transmitting gear train, by meansof which a lancet drive, an apparatus for advancing a magazine and asample transmitting apparatus can be coupled to the drive source. Astressing rotor and a drive rotor are rotably mounted co-axially to eachother. A first cam control converts the rotation of the drive rotor intoa radial forward and backward motion of a driving rod. A second camcontrol converts the rotational motion of the stressing rotor into alinear motion of a slotted-link slider. A switching slotted-linked movedby the slotted-link slider rotates the magazine one step further. Athird cam control converts the rotational motion of the stressing rotorinto a linear motion of a push rod perpendicular to the pricking axis.

In WO 2012/089524 A1, a lancet housing assembly is disclosed, includinga housing structure comprising multiple lancet compartments. At leastone lancet compartment comprises an outer facing side and an innerfacing side. A floor extends between the outer facing side and the innerfacing side. A reagent material is located on the floor and within thelancing compartment. A lancet structure is located in the at least onelancet compartment. The lancet structure comprises a skin-penetratingend and a blood transport portion. The blood transport portion isarranged and configured to receive the amount of blood from theskin-penetrating end and to carry the amount of blood away from the skinside to the reagent material.

WO 2012/140027 A1 discloses both analytical aids combined in a commonhousing and single analytical aids which may be handled independentlyfrom each other. The document further discloses a method for producingan analytical aid, comprising at least one housing and at least one testelement having at least one chemical test system.

In combined analytical devices containing a plurality of analytical aidsin a magazine, protection specifically may be provided on the side of ananalytical device using the magazine, such as the device disclosed in WO2011/044971 A1. Still, even in combined analytical aids having bothpuncture elements and detection means for detecting an analyte,protection against reuse may cause some major technical challenges.Specifically in case single analytical aids having one puncture elementstored therein, which may be handled independently from other analyticalaids, protection against reuse still is a technical issue. Thus,specifically for hygienic purposes and in order to prevent damage to ananalytical device using the analytical aid or sampling element,technical solutions protecting the sampling elements against reuse arehighly desirable.

Problem to be Solved

It is therefore an object of the present invention to provide a samplingelement and an analytical device which at least partially overcome theabove-mentioned technical challenges and problems of known samplingelements and analytical devices. Specifically, a simple, easy-to-useprotection against reuse shall be provided which, specifically, isapplicable to single sampling elements.

SUMMARY OF THE INVENTION

This problem is solved by a sampling element, an analytical device, amethod and a use according to the independent claims. Preferredembodiments which may be realized in an isolated fashion or incombination, as the skilled person will recognize, are listed in theindependent claims

As used in the following, the terms “have”, “comprise” or “include” orany arbitrary grammatical variations thereof are used in a non-exclusiveway. Thus, these terms may both refer to a situation in which, besidesthe feature introduced by these terms, no further features are presentin the entity described in this context, and to a situation in which oneor more further features are present. As an example, the expressions “Ahas B”, “A comprises B” and “A includes B” may both refer to a situationin which, besides B, no other element is present in A (i.e. a situationin which a solely and exclusively consists of B) and to a situation inwhich, besides B, one or more further elements are present in entity A,such as element C, elements C and D or even further elements.

Further, as used in the following, the terms “preferably”, “morepreferably”, “most preferably”, “particularly”, “more particularly”,“specifically”, “more specifically” or similar terms are used inconjunction with optional features, without restricting alternativepossibilities. Thus, features introduced by these terms are optionalfeatures and are not intended to restrict the scope of the claims in anyway. The invention may, as the skilled person will recognize, beperformed by using alternative features. Similarly, features introducedby “in an embodiment of the invention” or similar expressions areintended to be optional features, without any restriction regardingalternative embodiments of the invention, without any restrictionsregarding the scope of the invention and without any restrictionregarding the possibility of combining the features introduced in suchway with other optional or non-optional features of the invention.

In a first aspect of the present invention, a sampling element forgenerating a sample of a body fluid is disclosed. As used herein, asampling element, also referred to as an analytical aid, a puncture aidor a pricking aid, generally refers to an arbitrary element which isadapted to generate a sample of the body fluid by perforating a skinportion of a user, such as by lancing, pricking or cutting. Thus,specifically, the sampling element comprises a puncture element such asa lancet and/or needle.

The sampling element, as will be outlined in further detail below,preferably is a single sampling element, also referred to as a singletest, which contains precisely one puncture element and which may behandled in an isolated fashion, independently from other samplingelements. Thus, specifically, the sampling element may have preciselyone housing with precisely one chamber and/or puncture element containedtherein, without any further puncture elements and/or chambers, asopposed to combined magazines having a plurality of puncture elements asdisclosed in e.g. WO 2011/044971 A1 or WO2012/089524 A1.

As further used herein, a body fluid generally may refer to an arbitrarybody fluid of a human or animal user which may be generated bypuncturing a skin portion of the user. In the following, preferably,reference will be made to whole blood and/or interstitial fluid. Still,other body fluids are generally feasible.

The sampling element has a housing comprising a chamber with at leastone puncture element stored therein. As used herein, a housing generallyis an element providing protection against mechanical influences fromthe outside, such as protection against mechanical shocks. Thus, thehousing may provide a full or partial enclosure against the surroundingenvironment. Further, the housing may provide protection againstchemical influences, such as protection against moisture. The housingpreferably is at least partially made as a rigid housing, i.e. a housingwhich is not visibly deformed by forces usually occurring during use ofthe sampling element, such as forces due to the housing's owngravitational force. Thus, as an example, the housing may fully orpartially be made of a plastic material, such as one or more of theplastic materials disclosed in the method described in WO 2012/140027A1. Thus, as an example, one or more thermoplastic materials may beused.

As further used herein, a chamber generally is an open space containedwithin the housing which fully or partially is surrounded by thehousing. Most preferably, the chamber is fully surrounded by thehousing, notwithstanding the fact that the housing may contain one ormore openings, such as one or more puncture openings which will bedisclosed in further detail below.

As further used herein, a puncture element generally is an elementadapted for perforating a skin portion of a user, in order to create oneor more openings, punctures or incisions in the skin portion throughwhich the body fluid may be sampled and/or through which the body fluidmay leave a body tissue located underneath the skin portion. Thus,generally, the puncture element may be selected from the groupconsisting of a lancet or lancing element, a needle, a knife, amicro-sampler or a cannula. Most preferably, the puncture element is aneedle or a lancet. The lancet may be a flat lancet, a round lancet or alancet generally having an arbitrary cross-section, such as a polygonalcross-section. Generally, the puncture element may comprise an arbitrarytip for perforating, also referred to as puncturing, a skin portion ofthe user. The tip, as an example, may be a round needle tip or an acuteneedle tip.

Preferably, the puncture element comprises a micro-sampler, which is acombined element comprising both a tip for puncturing the skin portionand at least one capillary element for transporting body fluid from theskin portion and/or a tissue portion located underneath the skin portionby capillary forces. As an example and as will be outlined in furtherdetail below, the puncture element may comprise a flat lancet, such as aflat lancet generated by cutting and/or etching from a flat metal disc,with one or more capillary channels on at least one surface of thepuncture element, preferably one or more open capillary channels,preferably one or more capillary channels with hydrophilic properties.The one or more open capillary channels may comprise an at leastpartially opened slit or groove in a surface of the puncture element.The slit or groove may be straight or bent. The slit or groove may atleast partially be opened along its longitudinal extension. For furtherpotential embodiments of micro-samplers, reference may be made to one ormore of WO 2012/089524 A1 and WO 2012/140027 A1. Still, otherembodiments are feasible.

The tip of the puncture element is movable through at least one punctureopening of the housing in order to perforate a skin portion of the user.Thus, as an example, the housing may comprise a puncture opening leadingto the chamber, through which the tip of the puncture element is movablewhen performing a puncturing motion. As an example, the chamber may havean elongated shape, with a longitudinal axis, wherein the punctureelement is stored along the longitudinal axis within the chamber andwherein the puncture element may move along the longitudinal axis, inorder for the tip and, optionally, further parts of the punctureelement, to leave the chamber in order to perforate the skin portion ofthe user. The chamber preferably may be closed along the walls of thelongitudinal axis, and the puncture opening may be at a front face ofthe chamber. After perforating the skin portion of the user, thepuncture element may be retracted into the chamber and may be restoredwithin the chamber. Within the chamber, the puncture element may bestored in a relaxed state. Alternatively, the puncture element may bestored in a bent state, in order to keep the puncture element in placeby deformation, such as e.g. disclosed in WO 2012/140027 A1.Additionally or alternatively, other means for keeping the punctureelement in place when stored or restored within the chamber may bepresent.

The sampling element further comprises at least one compression element.The compression element may at least partially surround the punctureopening, preferably from an outside of the housing outside the chamber,as will be outlined in further detail below. The compression element isadapted to increase a pressure of the body fluid within a body tissue ofthe user in a region of puncturing when pressed onto the skin portion ofthe user. This process of forcing body fluid from a puncture openingcreated by a puncture element is also referred to as milking.

Compression elements, also referred to as compression units, expressionelements, expression units, expression rings or compression rings, aregenerally known in the art. Thus, as an example, compression units aredisclosed in EP 1 643 908 B1. Generally, as used herein, a compressionelement is an arbitrary element adapted for increasing an internalpressure within the body tissue which is fully or partially covered bythe skin portion to be perforated by the puncture element, in order toexpress body fluid out of an incision generated by the puncture element.The internal pressure preferably is created by mechanical forces only,which are exerted by the user pressing the compression element onto theskin portion, as opposed to other stimulation devices using, as anexample, heat, ultrasound and or other stimulation techniques. As willbe outlined in further detail below, the compression element maycomprise a ring-shaped protrusion which may fully or partially surroundthe puncture opening of the housing and/or which may fully or partiallysurround the puncture element during a lancing motion and which may bepressed onto the skin portion of the user, by a force exerted by theuser himself and/or the analytical device.

As proposed by the present invention, the compression element is movablymounted to the housing. Thus, the compression element and the housinggenerally are independent elements which may move relative to eachother, wherein the compression element is movably mounted to the housingby an arbitrary mounting mechanism. The sampling element provides atleast one locking mechanism for relcasably locking the compressionelement in at least two positions, the at least two positions comprisinga first position and a second position, the second position being offsetfrom the first position. Thus, the compression element is movablymounted to the housing and is movable when the locking mechanism isreleased. Thus, generally, the compression element may move at leastbetween the first position and the second position or vice versa whenthe locking mechanism is released. The second position, as an example,may be a position in which the compression element abuts the housingand, thus, may not move any further. Generally, the first position andthe second position may be end positions of a movement. Otherembodiments are feasible.

Preferably, the second position may be offset from the first position ina longitudinal direction of the sampling element, wherein, as anexample, the longitudinal direction of the sampling element may bedefined by a longitudinal extension of the chamber, by an axis oflongitudinal extension of the puncture element, a direction of apuncture motion or a combination thereof. Thus, generally, the nameddirections may be identical.

By movably mounting the compression element to the housing, a positionof the compression element, which may take at least two positions, mayfunction as an indication whether the sampling element has been used ornot. Thus, when the compression element is pressed onto the skin portionof the user, in a released state, the compression element may be pushedfrom the first position into the second position, thereby indicatingthat the sampling element has been used. The user and/or an analyticaldevice using the sampling element may recognize, by eye, by inspectionof the sampling element and/or by an arbitrary detector or detectionmechanism, whether the compression element is in the first position(indicating an unused state of the sampling element) or in the secondposition (indicating a used state of the sampling element) and,consequently, automatically or by any action taken by the user, preventa reuse of an already used sampling element. Thus, as an example, and aswill be outlined in further detail below, the analytical device maycomprise a mechanical mechanism such as a mechanical lock whichautomatically prevents a reuse of the sampling element when thecompression element is in the second position. As an example, theanalytical device may provide a lock and/or a blocking element whichautomatically prevents bringing a sampling element into an applicationposition in case the compression element is in the second position.Additionally or alternatively, the analytical device may provide adetection mechanism or detection device adapted for detecting whetherthe compression element is in the first position or in the secondposition and taking appropriate actions in case the second position isdetected, such as giving a warning to a user and/or automaticallyblocking a further use of the sampling element.

As outlined above, the compression element is movably mounted to thehousing. The movable mounting may allow for a motion of the compressionelement relative to the housing, preferably in the longitudinaldirection. As outlined above, the longitudinal direction generally maybe a direction of a puncture motion. The puncture motion may comprise aforward motion of the tip of the puncture element in order to perforatethe skin portion of the user and, optionally, a backward motion of thetip in order for the puncture element to be restored within the chamber,as disclosed e.g. in one or both of WO 2012/140027 A1 and WO 2012/089524A1. Thus, the second position may be offset from the first position in abackward direction or direction of the backward motion, which may alsobe the direction of a pushing force exerted onto the compression elementby the skin portion of the user when the compression element is pressedonto the skin portion. Thus, generally, the compression element may bepressed onto the skin portion in a direction perpendicular to a surfaceof the skin portion, which may be a direction of the forward motion ofthe tip of the puncture element, and, thereby, the compression elementmay be pushed in the direction of the backward motion.

Generally, the compression element may be linearly movable with regardto the housing. Preferably, the compression element may be linearlymovable parallel to a longitudinal axis of the sampling element.

The compression element may comprise at least one trigger portionadapted to exert a trigger action onto a trigger of an analytical deviceusing the sampling element when the compression element is moved fromthe first position into the second position. As used herein, a triggerportion generally refers to a part of the compression element whichprovides at least one leading edge or surface adapted for exerting thetrigger action when the compression element is moved from the firstposition into the second position. As an example, the trigger portionmay provide a rear face or rear surface, having at least one surfacecomponent facing into a rearward direction, adapted for providing atrigger force onto the trigger when the rear face or rear surface whenthe compression element is moved from the first position into the secondposition.

Thus, as an example, the analytical device using the sampling elementmay be adapted to automatically trigger the puncture motion when thecompression element is pushed from the first position into the secondposition. For this purpose, as will be outlined in further detail below,the analytical device may comprise at least one trigger mechanismadapted to trigger a lancing drive or puncture drive to drive thepuncture motion, wherein the trigger mechanism is adapted to be actuatedby the compression element when the compression element is moved fromthe first position into the second position. As an example, the triggerportion of the compression element may comprise an edge of thecompression element, preferably an edge or surface of a mounting portionof the compression element by which the compression element is mountedto the housing, and, more preferably, an edge or surface of at least onemounting arm of the compression element. When the compression element ismoved from the first position into the second position, the edge of thecompression element may engage the trigger mechanism of the analyticaldevice, which, as an example, may comprise a switch and/or a rocker,thereby triggering and/or releasing a puncture drive, also referred toas a lancing drive, and/or a coupling element to drive the puncturemotion. Trigger elements of this kind are generally known to the skilledperson and known in the art, such as from WO 2011/044971 A2 and/or fromEP 1 669 028 A1. Trigger mechanisms of this or similar kind may also beimplemented within the present invention, in combination with the ideaof using the compression element for triggering a trigger of ananalytical device.

As outlined above, the compression element is movably mounted to thehousing. Preferably, the compression element is movably mounted to thehousing such that, when the locking mechanism is released and when thecompression element is pressed onto the skin portion of the user, thecompression element is moved from the first position into the secondposition. Most preferably, the movement of the compression element is alinear movement.

As outlined above, the compression element generally is adapted toincrease a pressure of the body fluid within a body tissue of the userin a region of puncturing when pressed onto the skin portion of theuser. Thus, the region of puncturing may fully or partially besurrounded by the compression element when the compression element ispressed onto the skin portion. Specifically, the compression element maycomprise an annular compression element portion. Thus, the compressionelement may comprise one or more compression rings having an annularprotrusion, which at least partially surrounds the puncture opening ofthe housing and which is adapted to be pressed onto the skin portion inthe region of puncturing. The compression element may further have amounting portion movably mounted to the housing. The mounting may takeplace such that, in any position of the compression element, thecompression ring is located on a side of the housing facing the skinportion. The at least two positions of the compression element maysimply differ with regard to a distance between the compression elementand the housing.

As outlined above, the compression element may be mounted in a movablefashion to the housing by one or more mounting portions. Thus, as anexample, the at least one mounting portion may comprise at least onemounting arm, preferably at least two mounting arms and, mostpreferably, precisely two mounting arms, which is or are slidably guidedin one or more guidings of the housing. Thus, as an example, the guidingmay comprise one or more guide rails, such as a pair of guide rails,preferably at least two guide grooves. These guide grooves, however,preferably leave some clearance to allow an analytical device to takeover the guiding of the compression element when in use, as will bediscussed in more detail below.

The at least one mounting arm preferably may be or may comprise at leastone spring arm and/or may have elastic and/or flexible properties. Thus,the at least one mounting arm may fully or partially be designed as oneor more flexible or elastic plastic arms extending in a rearwarddirection from a body of the compression element, wherein the body ofthe compression element preferably comprises the at least one annularprotrusion facing in a forward direction.

The at least one mounting arm, preferably the pair of mounting arms,preferably may be or may comprise one or more snap aims adapted to snapinto at least one corresponding notch in the first position and thesecond position. Thus, the at least one mounting portion may comprise apair of snap arms which, as an example, may be guided in a pair of guiderails within the housing, which each are adapted to snap into one ormore notches in the first position and the second position. Thus, foreach snap arm, a first notch may be provided in the first position and asecond notch in the second position.

The housing, as discussed above, may fully or partially surround thechamber. The housing may be made of one piece or may be made of two ormore pieces. Thus, as an example, the housing may be composed of abottom part and a cover part.

As outlined above, the housing may comprise at least one guiding,preferably at least one guide rail, wherein the compression elementslidably is mounted into the guiding. Thus, as outlined above, thecompression element may comprise one or two mounting arms, preferablyone or two snap arms, which are movably or slidably mounted in the atleast one guide rail. The guiding preferably may extend along alongitudinal axis of the sampling element. Thus, as an example, the atleast one guide rail, which may be a slot-type guide rail or, morepreferably, a pair of slot-type guide rails within the housing,preferably may extend parallel to a longitudinal axis of the samplingelement.

As outlined above, the locking mechanism is adapted for releasablylocking the compression element in the at least two positions. As anexample, the locking mechanism may comprise a releasable snap-fitconnection. As used herein, a snap-fit connection is a connectioncomprising at least two connection elements interact by a form-fitconnection. Thus, as an example, the snap-fit connection may use elasticproperties of at least one of the connection elements. Thus, at leastone of the connection elements temporarily, during locking, may deformelastically, in order to, subsequently, engage the other connectionelement. As an example, the snap-fit connection may comprise at leastone snap hook and at least one catch, wherein the snap hook, afterappropriate elastic deformation, may engage with the catch. As anexample, the compression element may comprise the snap hook, such as byproviding one, two or more snap arms, and the housing may provide the atleast one catch, such as by providing two or more appropriate notchesfor engaging with the snap hook.

Thus, as outlined above, the compression element, preferably the atleast one mounting arm, may comprise at least one snap arm which isadapted to releasably snap into a first notch when the compressionelement is in the first position and into a second notch when thecompression element is in the second position. Thus, the at least onemounting arm generally may be designed as at least one snap arm. Thesnap arm, as outlined above, preferably provides flexible or elasticproperties. Other options are generally feasible.

As outlined above, the sampling element preferably is a disposablesampling element adapted for single use. Thus, the first position of thecompression element may be an unused position and the second positionmay be a used position. Preferably, the sampling element may containprecisely one puncture element and, thus, may be a disposable samplingelement adapted for single use. An appropriate analytical device may beadapted for recognizing whether the compression element is in the first,unused position or in the second, used position.

Thus, as an example, at least a part of the compression element mayprotrude from the housing and may form a protrusion from the samplingelement when the compression element is in the second position. Thisprotrusion may be indicative of the sampling element being used. Thus,an analytical device using the sampling element may recognize theprotrusion and, thus, may recognize that the compression element is inthe second position and, thus, is used. Consequently, the analyticaldevice may be adapted to perform several actions, such as preventing thesampling element from being used again, in case the protrusion isrecognized and/or blocking a puncture actuator and/or a coupling elementin order to block a puncture motion. Other options are feasible, such asa combination of the named options and/or a display of information to auser indicating that the sampling element has already been used.Further, the analytical device may be adapted to mechanically prevent aused sampling element from being brought into an application positionsuch as by providing one or more abutment portions abutting theprotrusion. As an example, the at least one protrusion may be formed byone or more of the mounting elements, such as by one or more of the snaparms. The protrusion, specifically, may also provide the above-mentionededge or surface of a mounting arm of the compression element, which,simultaneously, may be used for triggering a trigger mechanism.

As outlined above, the puncture element generally may be or may comprisean arbitrary type of lancet or lancing element. Further, the punctureelement may comprise additional elements, such as one or more elementsfor transporting and/or transferring a sample of the body fluid. Thus,as an example, the puncture element may comprise at least one capillary,also referred to as a capillary element, adapted to receive body fluidfrom the region of puncturing. The at least one capillary may startimmediately at the tip of the puncture element or may be offset from thetip of the puncture element. Thus, as an example, the at least onecapillary may start at a distance of 0.3 to 2 mm from the tip of thepuncture element. Other embodiments are feasible. The capillary elementpreferably may extend along a longitudinal axis of the puncture element.The capillary, as an example, may be adapted to receive body fluid fromthe region of puncturing, wherein the body fluid received within thecapillary fully or partially forms the sample of the body fluid. Thus,when referring to a sample of the body fluid, reference may be made tothe whole body fluid received by the sampling element or to a partthereof. The capillary may be adapted to receive the body fluid and,optionally, may be adapted to transfer the body fluid onto another partof the sampling element and/or the analytical device, such as onto atest field and/or a test chemical contained within the sampling elementand/or contained within the analytical device. As an example, thepuncture element may be or may comprise a micro-sampler having at leastone capillary slot. The capillary slot preferably may be located on asurface of the puncture element. Thus, as an example, the punctureelement may be a flat micro-sampler which may be produced by embossingand/or etching a flat disc. The sampling element may be adapted to leadthe at least one capillary slot close to an optional test field of thesampling element when the puncture element is retracted into thechamber, thereby allowing for a transfer of the sample of the body fluidonto the test field. Further optional details will be given below.

As outlined above, the sampling element may be a sampling element forpuncturing purposes only. Thus, the sampling element may be a purepuncture aid, without any further functions, preferably asingle-puncture element sampling element for single use. Alternatively,the sampling element may comprise additional functions, such as at leastone detection function. Thus, preferably, the sampling element may be acombined sampling element, providing both puncture function andanalytical function.

Thus, as an example, the sampling element may further comprise at leastone test chemical adapted for performing at least one detectabledetection reaction in the presence of at least one analyte to bedetected. The sampling element, as outlined above, may be adapted totransfer body fluid onto the test chemical, such as by transferring abody fluid from the puncture element, preferably the microsampler, ontothe test chemical, more preferably onto a test field comprising the atleast one test chemical.

Generally, as used herein, a test chemical is a chemical substanceand/or a mixture of chemical substances adapted for performing at leastone detectable detection reaction when the analyte is present. As anexample, the detection reaction may be an electrically detectable and/oran optically detectable detection reaction. In the following, referencewill be made to optical detection reactions which is the preferredoption within the present invention. Generally, the test chemical may beor may comprise an arbitrary substance or mixture of substances adaptedfor performing the at least one detection reaction. For potential testchemicals, also referred to as test chemistries and/or detectorchemicals and/or detector substances, reference may be made to the priorart. Thus, as an example, reference may be made to WO 2012/140027 A1 andthe test chemicals disclosed therein, which may also be used within thepresent invention. Thus, preferably, the test chemical is a testchemical stable against environmental influences, preferably stableagainst humidity, as defined in WO 2012/140027 A1. Still, other testchemicals may be used.

Most preferably, the at least one test chemical includes at least oneenzyme adapted to perform at least one enzymatic reaction in thepresence of the analyte to be detected. As an example, in case glucoseis to be detected, the enzyme may comprise glucose oxidase and/orglucose dehydrogenase. Further, the at least one test chemical maycomprise one or more mediators and/or one or more co-enzymes. Further,the at least one test chemical may comprise one or more dyes, which,when the analyte is present and when the detection reaction takes place,are adapted for performing a color change and/or another type ofoptically detectable change, such as a change in fluorescenceproperties.

For performing a transfer of the body fluid onto the test chemical,several techniques are feasible. Thus, as outlined above, the testchemical may be located close to the puncture element when the punctureelement is stored within the chamber. As an example, the punctureelement, after performing the puncture motion, may be guided by anappropriate internal guiding structure of the chamber, such that thepuncture element and/or a part thereof, such as the at least onecapillary, are guided close to the at least one test chemical such asclose to at least one test field comprising the at least one testchemical. For potential details of this option, reference may be made toone or both of WO 2012/089524 A1 and WO 2012/140027 A1. Additionally oralternatively, the puncture element may be pressed onto the testchemical and/or the test field. Various other types of sample transferare known.

As outlined above, the test chemical preferably may be contained in atleast one test field. As used herein, a test field generally refers to acoherent amount of the test chemical forming one or more layers, thetest field preferably having at least one test field surface and/orapplication surface. In addition to one or more layers containing the atleast one test chemical, the test field may comprise additionalelements, such as one or more additional layers. Thus, as an example,the test field may comprise at least one test chemical layer comprisingthe at least one test chemical and, preferably, one or more additionallayers, such as one or more separation layers for separating offunwanted parts of the sample of the body fluid, such as red blood cells,and/or one or more layers having reflecting properties, such as one ormore pigment layers providing a bright, preferably a white, backgroundfor measurement. Thus, the test field may comprise a multi-layer setupwith at least one test-chemical layer and at least one cover layer, suchas at least one separation layer and/or at least one pigment layer,covering the at least one test chemical layer. The test field surfacemay be a surface of the at least one cover layer, such that the sampleof the body fluid is applied to the at least one cover layer and has topenetrate the at least one cover layer before reaching the at least onetest chemical layer. Still, other layer setups are feasible, such assingle-layer setups containing the test chemical layer, only.

Most preferably, the test chemical is accessible from the chamber. Thus,the test field may be accessible from the chamber. As an example, one ormore walls of the chamber may provide one or more windows, i.e. one ormore openings, which fully or partially are covered by the test fieldsuch that the test field is fully or partially accessible from aninterior of the chamber. Consequently, the test field and/or a partthereof may form a part of at least one wall of the chamber, such thatsample fluid transferred into the chamber by the puncture element may betransferred from the puncture element onto the test field inside thechamber. Thus, the sampling element may be adapted to take up the sampleof the body fluid with puncture element in a puncture motion of thepuncture element and to transfer the sample of the body fluid from thepuncture element onto the test chemical, such as by approximating thepuncture element to the test field containing the test chemical,preferably within the chamber. Consequently, the sampling element may beadapted to bring the puncture element close to the test chemical whenthe puncture element is pulled back into the chamber, such as in arearward motion of the puncture element, after the puncture motionand/or as a part of the puncture motion. As outlined above, the chamberwalls may provide an appropriate guiding structure for the punctureelement, in order to lead the puncture element close to the testchemical, preferably close to the test field.

The housing, as outlined above, may comprise one or more openings, suchas the puncture opening. The housing may further comprise at least oneactuator opening adapted for a coupling element to enter the chamber andto engage with the puncture element in order to drive the punctureelement for a puncture motion. The coupling element specifically may bepart of a puncture actuator and/or may be coupled to a puncture drive orlancing drive of an analytical device. The coupling element may move inone or more dimensions, such as in a longitudinal direction and,optionally, in one or more directions perpendicular to the longitudinaldirection. Thus, the coupling element may be a z-actuator, an xz-, a yz-or an xyz-actuator. Additionally or alternatively, however, the couplingelement may be adapted to rotate or pivot around at least one axis, suchas an axis perpendicular to the longitudinal direction. The analyticaldevice may comprise one or more puncture drives, also referred to as alancing drive which may permanently or releasably be coupled to thecoupling element for driving a puncture motion. The at least onepuncture drive may comprise an arbitrary driving mechanism for driving apuncture motion or lancing motion, such as one or more spring mechanismsgenerally known in the art.

As an example, the at least one actuator opening may be located at anend of the housing opposing the end of the housing containing thepuncture opening Generally, as used herein, a coupling element is anarbitrary element or actuator which is adapted for driving the punctureelement to perform a puncture motion. As an example, the couplingelement may comprise one or more movable hooks and/or one or moremovable ramps. Potential embodiments of the coupling element, referencemay be made to one or more of the above-mentioned prior art documents,such as WO 2011/044971 A2 and/or WO 2012/089524 A1. Still, otherembodiments are feasible.

The coupling element, as outlined above, may be connected to, may beconnectable to or may be part of at least one drive element of theanalytical device. The at least one optional drive element and the atleast one coupling element, in conjunction, may form a puncture actuatorof the analytical device. Generally, as used herein, a drive elementrefers to an arbitrary actuator adapted for driving the puncture elementto perform the puncture motion. The drive element generally may comprisean arbitrary driving mechanism, such as one or more of the drivingmechanism is disclosed in WO 2011/044971 A2 and/or WO 2012/089524 A1.

The coupling element may engage with the puncture element in thegenerally arbitrary fashion in order to drive the puncture element for apuncture motion. Thus, the coupling element may simply push the punctureelement in a forward motion. Additionally or alternatively, the couplingelement may also be adapted for pulling back the puncture element afterthe puncture motion, i.e. after a forward motion of the punctureelement, in order to perform a rearward motion and/or in order tore-store the puncture element within the chamber. Thus, as an example,the puncture element may comprise one or more hooks which may be adaptedto engage with one or more openings of the puncture element.

The puncture element may comprise at least one connection elementadapted to engage with the at least one coupling element for beingdriven to perform the puncture motion. Thus, as an example, the at leastone connection element, as outlined above, may comprise one or moreopenings within the coupling element, preferably at a rearward end ofthe puncture element opposing the tip of the puncture element. Thus, theconnection element may comprise at least one opening adapted to beengaged by the coupling element, e.g. a hook of the coupling element.

The sampling element, as an example, may have a total volume of lessthan 3 cm³, preferably a total volume of 0.5 to 2 cm³. As an example,the sampling element may have a length of 3 mm to 30 mm, preferably alength of 5 mm to 20 mm, and may have a width and/or height of 2 mm to20 mm. The sampling element may have a circular and/or squarecross-section in a plane perpendicular to a longitudinal axis ofextension. Other embodiments are feasible.

The compression element preferably may have a contact area which, duringcompression, gets in contact with a skin of the user. The contact area,as an example, may be a surface area of the annular protrusion. Thus, asan example, the contact area may be an annular or circular area. As anexample, the contact area may be a ring-shaped area having a ring with(i.e. a difference between an outer radius and an inner radius) of 0.2to 3 mm, preferably 0.3 to 2 mm and more preferably 0.5 to 1 mm. Thecontact area, as an example, may be in the range of 0.5 to 30 mm²,preferably in the range of 1 mm² to 20 mm². Other embodiments arefeasible. The annular protrusion, as an example, may have a diameter of2 to 10 mm, preferably a diameter of 3 mm to 5 mm.

The compression element may be adapted to actuate a trigger of ananalytical device using the sampling element. Typically, the compressionelement may be pressed onto the skin of the user by forces of more than1 N, such as forces of 2 to 30 N, 3 to 15 N or 5 to 10 N. The triggermay be adapted such that an actuation by the compression element withtrigger forces of more than 1 N may lead to a trigger action. Thus, thetrigger may be adapted to initiate a puncture motion once a triggerforce exceeding a trigger threshold is exerted onto the trigger by thecompression element. The trigger force may be in the range of 0.5 N to10 N or 1 N to 10 N. Other embodiments are feasible.

The compression element preferably may fully or partially be made of amaterial which is break-proof, at least under typical forces occurringduring normal use, such as forces up to 20 N, preferably up to 30 N.Further, the compression element may fully or partially be made of aflexible and/or elastic material. Specifically, the compression elementmay comprise a mounting portion, specifically a mounting portion havingat least one mounting arm. The mounting portion, specifically the atleast one mounting arm, preferably may fully or partially be made of atleast one flexible and/or elastic material. As an example, at least oneplastic material may be used, such as at least one thermoplasticmaterial. As an example, one or more of the following materials may beused: a polycarbonate (PC); a polyester (PE); an acrylonitrile butadienestyrene (ABS); a cyclo olefin copolymer (COC); a poly(methylmethacrylate) (PMMA); a polystyrene (PS); a polyethylene terephthalate(such as PET, PETE, PETP or PET-P). Further, other materials and/orcombinations of two or more of the named materials and/or combinationsof one or more of the named materials with one or more other materialsmay be used. Specifically, the compression element, more preferably theprotrusion, may fully or partially be made of a skin-compatible orskin-tolerant material, preferably a material which is not prone toprovoke allergies.

The at least one mounting arm may, as a whole or as a part, be part ofthe locking mechanism. Thus, as an example, a rear end of the mountingarm may be bent in order to release the locking mechanism.

As outlined above, the sampling element preferably is a single samplingelement, i.e. a sampling element which contains precisely one punctureelement. Thus, the housing may contain precisely one chamber with theprecisely one puncture element located therein. Preferably, the samplingelement may be a disposable single-use sampling element. The samplingelement, preferably the single sampling element, may be packaged, suchas by using commonly known packaging technologies. Thus, as an example,a single sampling element may be packaged in a compartment of apackaging. As an example for commonly known packaging technologies, usemay be made of one or more of vials, blister packs or packaging stripssuch as tablets strips. Other packaging technologies are feasible. As anexample, single sampling elements may be packaged in a loose fashion,such as one by one, in respective compartments of blister packs orvials. An advantage of the present invention, with the compressionelement being an element separate from the housing, resides in the factthat the sampling elements may be packaged such that the single samplingelements and/or their chambers may be sealed individually and, thus, maybe protected against detrimental effects of moisture and/or air. Thus,as an outer packaging, simple cardboard packages or other packageswithout sophisticated protective properties against moisture and/or airmay be used.

Still, in a further aspect, an analytical magazine is disclosed having amagazine housing and having a plurality of sampling elements as proposedwithin the present invention stored therein. Preferably, the samplingelements are stored independently from each other within the analyticalmagazine, i.e. without mechanical connection and/or without beingcombined by a common housing. Thus, the sampling elements preferably arestored and may be handled independently from each other.

In a further aspect of the present invention, an analytical device isdisclosed, the analytical device being adapted for using the samplingelement according to the present invention, such as the sampling elementaccording to one or more of the above-mentioned embodiments and/or thesampling element according to one or more of the embodiments disclosedin further detail below. The analytical device comprises at least onecoupling element adapted for driving the puncture element to perform apuncture motion. Further, as outlined above, the analytical device maycomprise at least one driving element which may fully or partially beconnected or connectable to the coupling element. As outlined above, thedriving element and the coupling element, in conjunction, may form apuncture actuator adapted for driving the puncture element to perform apuncture motion. The driving element also may be referred to as thelancing drive or the puncture drive. With regard to potentialdefinitions and embodiments of the coupling element, the driving elementand the puncture actuator, reference may be made to the disclosure givenabove. Further, reference may be made to the coupling elements, driveelements and puncture actuators as disclosed in one or more of theabove-mentioned prior art documents, such as in WO 2011/044971 A1 and/orWO 2012/089524 A1. Thus, generally, the analytical device may compriseone or more release elements and, optionally, one or more release driveelements driving the one or more release elements. The at least onerelease element and the at least one optional release drive element, inconjunction, may form at least one release actuator.

The at least one coupling element may be driven by an arbitrary driveelement contained within the analytical device, such as by a motorand/or a rotor and/or a spring element contained within the analyticaldevice. Thus, for driving the coupling element, the drive element maycomprise one or more of a motor, such as an electrical motor, a springelement, such as a coil spring and/or another type of spring element, amechanical and/or electrical energy storage adapted for providing energyto be transformed into the puncture motion.

The analytical device further comprises at least one release element,the release element being adapted for releasing the locking mechanism ofthe sampling element in the first position before performing thepuncture motion in order to allow for the compression element of thesampling element to be moved from the first position into the secondposition. Thus, generally, a release element, as used herein, is anarbitrary element or an arbitrary combination of elements adapted forreleasing the above-mentioned locking mechanism. In a most simple case,as will be outlined in further detail below, the release element maycomprise one or more bars, also referred to as release bars, which maybe pushed in between the compression element and the housing of thesampling element, such as in between a mounting arm, more preferably asnap arm, of the compression element and the housing, in order torelease the mounting element from the housing. Thus, as an example, ahook contained in the snap arm may be lifted from a notch within thehousing, in order to allow for the compression element to be movedrelative to the housing. Most preferably, during moving the compressionelement, the housing is kept in a fixed position by the analyticaldevice and, thus, does not move with regard to the analytical device.Therefore, the housing preferably leaves enough clearance for thecompression element to hand over the guiding of the compression elementto structures of the analytical device. This preferred embodiment allowsthe compression element to be moved by force, such as a force exerted bythe compression element onto the skin of the user, without disturbingthe position of the housing within the analytical device.

As outlined above, the coupling element may comprise at least one hookadapted to engage with an opening of the puncture element of thesampling element. Still, other types of coupling elements are feasible,as discussed above.

As outlined above, the release element may comprise at least one releaseelement bar adapted to be pushed in between at least a part of thecompression element and the housing of the sampling element in order torelease the locking mechanism. As an example, the at least one releaseelement bar may comprise a wedge which may be forced in between thecompression element and the housing, such as in between at least onemounting portion of the compression element and, more preferably, inbetween a snap arm of the compression element and the housing, in orderto release the locking mechanism. The wedge, as an example, may belocated at a free end of the release element bar. Preferably, at leasttwo release element bars are comprised, each comprising a wedge at itsfree end facing towards the sampling element.

The coupling element and the release element may be driven independentlyor, preferably, may be driven by a link mechanism. As used herein, alink mechanism generally refers to a mechanism which is adapted to fullyor partially couple the motions of the coupling element and the releaseelement. The link mechanism thus may comprise one or more arbitraryelements adapted to couple these motions. The coupling of the motions bythe link mechanism may comprise a coupling in the same direction ofmotion or in different directions. Further, the link mechanism maycomprise a differential and/or may comprise a gear drive having a fixedor variable gear transmission ratio. The coupling element and therelease element may further be driven by a combined actuator or driveor, preferably, by independent actuators or drives. Thus, as outlinedabove, the coupling element may be driven by at least one drive element,and the release element may be driven by at least one release driveelement. These drive elements each may comprise an arbitrary type ofactuator, as outlined above with regard to the drive element of thecoupling element. The drive element of the coupling element and therelease element and the link mechanism, in conjunction, may form acommon drive of the coupling element and the release element.

The process of using the sampling element may comprise at least twophases, a preparation phase and a lancing and/or sampling phase. Duringthe preparation phase, the coupling element may engage the lancingelement and, preferably at least partially simultaneously, the releaseelement may release the locking mechanism, thereby releasing thecompression element from the housing of the sampling element. Thismovement preferably may be relatively slow, such as some millimeters persecond up to some centimeters per second. During the lancing phase, thepuncture element may be moved relatively fast, such as in the order ofone or more meters per second. This can be performed by two individualactors, i.e. the drive element and the release drive element, which mayspecialized to their tasks and may act separately on the couplingelement and the release element. Alternatively, as outlined above, acombination of these actuators is also possible. As known from EP 1 669028 and WO 2011/044971 A2, however, especially the drive element of thecoupling element can do a preparation stroke as well as a lancingstroke. This combination, however, may lead to a drive with relativelylong movement distances and, thus, may lead to large steering curveswith the inherent friction issues. Alternatively, the release driveelement, which may also be referred to as the preparation drive, canmove the entire lancing drive forward and backward to do the preparationmovement of the coupling element which afterwards does the lancingstroke at high velocity. This typically means to provide the space notonly of the lancing drive but also for moving it around. Additionallythese combined drives may become the more restricted in fitting into asmall device the more tasks they have to do. Thus, generally, variouspossibilities of driving the release element and the coupling elementare possible and may be realized within the present invention.

Still, as outlined above, the analytical device preferably comprises atleast two actuators which, preferably, independently may drive thecoupling element and the release element. Thus, the analytical devicemay comprise at least one drive element for driving the coupling elementand may comprise at least one release drive element for driving therelease element. These drive elements preferably are specialized driveselements and, preferably, may act independently. The drive elements mayact on the link mechanism which leads their motions to the couplingelement and, specifically in case of the preparation phase, to thecoupling element and the release element as well. The drive elements inconjunction with the link mechanism may act in the fashion of aninversely operating differential drive known from automotive technology.Still, the link mechanism may provide limited linear motions, preferablyin a sequential fashion, rather than continuous rotation of motions asknown in automotive differential drives.

The drives, i.e. the drive element and the release drive element, eachindependently may comprise one or more of: one or more motors, one ormore spring elements, one or more gears or similar elements whichgenerally are well known to one skilled in the art.

The drives, i.e. the drive element for driving the coupling element andthe release drive element for driving the release element, may actentirely independently from each other. As outlined above, however, italso is possible to connect these drives. For instance, the releasedrive element, which may also be referred to as the drive for thepreparation phase, may be or may comprise a simple push button whichalso may act as a cocking means for the lancing drive as e.g. isdescribed in EP 1 384 438 B1 (FIG. 4). While doing the forward movementof the release element and the coupling element it may tension, e.g. bymeans of rack and pinion, the drive spring which later drives thelancing motion. Additionally or alternatively, the preparation movementmay be performed by rotating the cocking element while the puncturemotion may be driven by a spring-driven lancing element, such as in EP 1669 028 A1.

As outlined above, the analytical device may comprise a link mechanismfor driving the coupling element and the release element. The linkmechanism may comprise at least one lever directly or indirectlyconnected both to the coupling element and to the release element. As anexample, the lever may comprise one, two or more rotational axes. Incase a plurality of rotational axes, such as two rotational axes, areused, the rotational axes may be used alternatively. Thus, as anexample, the lever may comprise a rotational axis, wherein the driveelement and/or the coupling element may be connected to the lever on afirst arm with regard to the rotational axis, and wherein the releaseelement and/or the release drive element may be connected to the leveron a second, opposing arm of the lever, such that the rotational axis islocated in between the connection of the coupling element and theconnection of the release actuator. A distance between the rotationalaxis and a connection point of the drive element and/or the couplingelement, respectively, and a distance between the rotational axis and aconnection point of the release element and/or the release driveelement, respectively, may determine the respective transmission ratiosor gear ratios of the lever, which, by adjusting these distances, may beadjusted. Further, the stroke of the respective actuators may beadjusted by these distances.

The coupling element and the release element may be mountedindependently. Still, preferably, the release element and the couplingelement may be mounted on a common mounting. Thus, the coupling elementand the release element may be mounted on a common guide, such as alinear guide. Thus, as an example, the guide may comprise one or moreslides and/or one or more slide rails or slide bars on which the releaseelement may be mounted, in order to perform a linear motion, preferablyin the direction of the puncture motion. Preferably, the couplingelement and the release element may be mounted on the common guide andmay be movable independently on this guide.

The release element, in one embodiment, may be spring-biased, preferablyin order to reengage the locking mechanism and to disengage the couplingelement form the puncture element after the puncture motion, such as thelancing or sampling action, has taken place. Thus, as an example, therelease element may perform a forward motion, such as a forward motiondriven by the preparation drive, in order to release the lockingmechanism. Thus, as outlined above, a wedge contained in the releaseelement may be pushed in between a part of the compression element andthe housing, in order to release the locking mechanism, such as in orderto release one, two or more snap arms. As outlined above, duringtriggering of the puncture motion and/or during use of the samplingelement, the compression element may move from the first position to thesecond position. During that movement, the release element may be keptin position in order to keep the locking mechanism unlocked or released,at least until the compression element has reached the second position.The spring-biasing may comprise at least one spring element adapted topull or push the release element in a backward direction. The releaseelement may be held in a forward position until the lancing has takenplace and then may be allowed to retract.

As discussed above, the analytical device may further comprise at leastone trigger mechanism adapted to trigger a puncture motion of thepuncture element. Thus, the trigger mechanism may be adapted to triggera lancing drive acting directly or indirectly onto the puncture element.The trigger mechanism may be adapted to be actuated by the compressionelement, when the compression element is moved from the first positioninto the second position. A compression force may be provided by thetrigger mechanism and may be transmitted to the skin by the compressionelement. Thus, as discussed above, the trigger mechanism may betriggered by a trigger portion of the compression element, such as anedge of the compression element, preferably an edge of a mountingportion of the compression element and, more preferably, an edge of atleast one mounting arm of the compression element, such as an edge of asnap arm. Most preferably, the edge is a rearward-facing edge, i.e. anedge facing in a direction opposing a forward motion of the tip of thepuncture element. Thus, the forward direction may be a direction towardsthe skin portion of the user, whereas a rearward direction may be adirection away from the skin portion of the user. As an example, thetrigger mechanism, as outlined above, may comprise a rocker and/or pushbutton which, again, may act on the drive element and/or the couplingelement, in order to release a forward motion of the puncture element.These types of trigger mechanisms are generally known in the art. Withinthe present invention, the trigger mechanism may be triggered by thecompression element, preferably by a rearward motion of the compressionelement.

As outlined above, the position of the compression element may be usedfor detecting whether the sampling element has already been used or not.Thus, in a simple fashion, a protection against reuse may be provided ina rather simple fashion, simply by detecting the position of thecompression element. Thus, as an example, the analytical device may beadapted to prevent the coupling element and/or the drive element todrive the puncture motion when the compression element is found to be inthe second position, thereby preventing a reuse of a used samplingelement, i.e. a reuse of the sampling element in case the sampling isfound to be a used sampling element. The preventing of the drive elementto drive the puncture motion may take place in various ways. Thus, asoutlined above, the drive element itself may be blocked and/or therelease drive element may be blocked so that the coupling element maynot engage with the puncture element.

Additionally or alternatively, other types of protection against reusemay be implemented. Thus, as an example, the analytical device may beadapted to prevent the sampling element to be located in an applicationposition of the analytical device when the compression element is foundto be in the second position, thereby preventing a reuse of a usedsampling element, i.e. preventing a reuse of the sampling element incase the sampling element is found to be a used sampling element. Asused herein, an application position generally is a position of theanalytical device in which a sampling element may be held and a puncturemotion may be driven by the analytical device. The analytical device mayprovide one or more application positions. As an example, the analyticaldevice may provide a housing with a predetermined space containedtherein adapted for receiving one or more sampling elements, wherein apuncture motion and, thus, a sampling of the body fluid, may take placewhen the sampling element is in the application position. The analyticaldevice may provide one or more means transferring one or more samplingelements into the application position, such as one or more transportingmeans. Thus, as an example, the analytical device may make use of one ormore analytical magazines as disclosed above, preferably one or moreanalytical magazines having sampling elements stored therein which maybe handled independently from each other. The analytical device may beadapted such that the sampling elements, one after the other, may betransferred into the application position. The analytical device mayprovide a simple blocking mechanism adapted for blocking a samplingelement to be brought or transferred into the application position incase the compression element is found to be in the second position.Thus, as an example, as discussed above, at least a part of thecompression element may protrude from the housing and may form aprotrusion from the sampling element when the compression element is inthe second position. The blocking mechanism of the analytical device maybe adapted to abut the protrusion, thereby preventing the used samplingelement to be transferred into the application position. Thus, as anexample, the blocking mechanism may be shaped like a fish trap or aweir, in order to abut the at least one protrusion, thereby preventing aused sampling element to be transferred into the application position,whereas, in case no protrusion is present, the blocking mechanism allowsfor the sampling element (which, in this case, is an unused samplingelement) to be transferred into the application position.

The analytical device may further comprise at least one sampling elementaccording to the present invention, such as according to one or more ofthe embodiments disclosed above and/or according to one or more of theembodiments disclosed in further detail below. As an example, theanalytical device may comprise a plurality of the sampling elements.Preferably, the analytical device may be adapted to transfer thesampling elements, one after the other, into an application position ofthe analytical device, in which the sampling may take place. Thus, as anexample, the analytical device may comprise one or more analyticalmagazines as disclosed above, such as according to one or more of theembodiments disclosed above and/or according to one or more of theembodiments disclosed in further detail below.

Preferably, the analytical device may be adapted to subsequently move ortransfer sampling elements into the application position and to performa puncture motion by using the sampling element in the applicationposition.

As outlined above, the at least one sampling element may be a purepuncturing sampling element, i.e. a sampling element having the punctureelement only, without any further detection element. Alternatively andmore preferably, the sampling element is a combined sampling element,which, besides puncturing the skin portion of the user, provides one ormore additional analytical functions and/or one or more additionalanalytical aids. Thus, as an example and as discussed above, the atleast one sampling element further may comprise at least one testchemical adapted for performing at least one detectable detectionreaction in the present of at least one analyte to be detected. As anexample, the test chemical may be an optical test chemical adapted forperforming at least one optically detectable detection reaction in thepresence of the least one analyte to be detected, such as a detectionreaction implying a change of a color and/or implying a change offluorescence or reflective properties of the test chemical. The at leastone property may be an indication of a progress of the detectionreaction and, thus, may be an indication of a quantity of the analytewithin the sample, such as a concentration of the analyte.

Consequently, the analytical device may further comprise at least onedetector adapted to detect at least one detection reaction of a testchemical contained within the sampling element. Above, the detectorpreferably may be or may comprise an optical detector adapted to detectan optically detectable detection reaction of the test chemical. Thus,as an example, the optical detector may comprise at least one lightsource adapted to illuminate the test chemical of the sampling element,such as to illuminate at least one test field containing the at leastone test chemical. Additionally or alternatively, the detector maycomprise at least one light-sensitive element adapted to detect lightpropagating from the test chemical to the detector. The lightpropagating from the test chemical to the detector may be light emittedby the test chemical, such as fluorescence light and/or phosphorescencelight, and/or may be light which is reflected and/or diffused by thetest chemical. Thus, as an example, the detector may be adapted toperform a reflection measurement or reflective measurement, in order todetermine a remission property of at least one test field containing theat least one test chemical. Thus, the light source may be adapted toilluminate the at least one test field, and the light-sensitive elementmay be adapted to detect light reflected and/or remitted by the testfield. The light-sensitive element generally may be an arbitrary elementadapted to detect light and to generate an electrical signal indicatingan intensity of the light. Thus, as an example, the light-sensitiveelement may be or may comprise a photodiode, a photo sensor, a solarcell and/or a combination thereof.

In order to perform an optical measurement, as outlined above, thehousing of the sampling element may comprise one or more detectionopenings, such as one or more windows through which the test chemical,preferably the test field, may be monitored by the detector. Thus, as anexample, the housing may comprise a front face having the punctureopening, may comprise a rear face opposing the front face, the rear facepreferably having the actuator opening, and, additionally, side faces onlongitudinal sides of the housing, one or more of the side faces havingthe at least one detector opening. Within the chamber, the detectoropening may fully or partially be covered by the test field. Thus, thetest field may be applied to one or more carrier elements, or preferablya transparent carrier element, wherein the carrier element, from aninterior side of the chamber, is applied to the detection opening.Through the detection opening and through the carrier element, theabove-mentioned optical detection of the detection reaction may takeplace.

Further preferred embodiments refer to the above-mentioned use of theanalytical device. Thus, the analytical device may be adapted to performthe following steps, preferably in the given order. Still, other ordersof the steps are feasible. Further, it is possible to perform two ormore of the steps simultaneously or in an overlapping fashion. Further,it is also possible to perform one, two or more of the steps repeatedly.Further, additional steps may be comprised which are not mentioned inthe following. The steps are as follows:

-   a) releasing the locking mechanism by using the release element;-   b) driving the puncture element to perform a puncture motion by    using the coupling element, thereby generating the sample of the    body fluid-   c) at least partially transferring the sample of the body fluid onto    the test chemical;-   d) detecting the detection reaction by using the detector.

Step a) preferably may further imply the step of engaging the punctureelement by using the coupling element, preferably at least partiallysimultaneously to the step of releasing the locking mechanism.

In step b), the coupling element preferably may be driven by the driveelement.

In step c), transferring the sample of the body fluid onto the testchemical preferably may be performed by disengaging the coupling elementfrom the puncture element.

As outlined above, the transfer of the body fluid onto the test chemicalpreferably may take place by one or more transfer elements containedwithin the sampling element, such as by one or more capillary elements,most preferably by one or more capillary slits contained within thepuncture element. As further outlined above, the sampling element may beadapted, during a rearward motion of the puncture element, to bring thetransfer element, such as the capillary channel, close to the testchemical, such as close to the test field, in such proximity that thesample contained within the transfer element is transferred onto thetest field by wetting. Thus, as an example, the housing may comprise,within the chamber, a guiding which, during a rearward motion of thepuncture element, leads the puncture element close to the test chemical.Additionally or alternatively, the puncture element may be pressed ontothe test chemical, such as onto the test field.

The analytical device may further be adapted to perform the followingstep:

-   c) determining a concentration of at least one analyte in the body    fluid by evaluating at least one signal generated by the detector.

For detecting the signal, such as a photometric signal, preferably asignal indicating a remission of a test field, reference may be made tothe prior art documents. Thus, a change in color may be detected byusing appropriate remission measurements, the change in color indicatinga degree of the detection reaction and, thus, indicating the presence ofthe analyte. These methods are generally known in the art.

In a further aspect of the present invention, a method of generating asample of the body fluid is disclosed. The method comprises a use of theanalytical device according to the present invention, such as accordingto one or more of the embodiments disclosed above and/or according toone or more of the embodiments disclosed in further detail below. Themethod comprises the following steps, which, preferably, may beperformed in the given order. However, a different order is possible. Itis also possible to perform two or more of the method stepssimultaneously or in an overlapping fashion. Further, it is possible toperform one, two ore more of the method steps repeatedly. The method maycontain additional method steps which are not mentioned in thefollowing. The method steps of the method are as follows:

-   i) releasing the locking mechanism by using the release element;-   ii) driving the puncture element to perform a puncture motion by    using the coupling element, thereby generating the sample of the    body fluid.

For further details of the method, reference may be made to thedisclosure of the analytical device and/or the sampling element, asdiscussed above. Specifically, the method may be performed such that nomedical expert knowledge is required. The method may be performed by apatient or user himself or a medical assistant. The method specificallymay be performed such that no substantial physical intervention on thebody of the user occurs. Specifically, the puncture motion may beperformed such that only a minor opening in the skin of the user iscreated, such as an opening which produces only minor amounts of bodyfluids such as blood. Thus, the method specifically may be performedsuch that amounts of the body fluid of less than 1 ml are created,preferably amounts of less than 0.5 ml or even less than 100 less than10 μl or even less than 1 μl.

In a further aspect, a use of a position of a compression element forindicating a used or unused state of a sampling element, for the purposeof preventing unwanted reuse of the sampling element is disclosed. Asoutlined above, the compression element is adapted to increase apressure of a body fluid within a body tissue of a user in a region ofpuncturing. Thus, the general aspect of using the position of thecompression element for unwanted reuse of the sampling element isproposed.

The sampling element, the analytical device, the method and the useaccording to the present invention provide a large number of advantagesover known devices and methods of this type. Thus, specifically, singletests for one single use may be provided which may be handledindependently and which, preferably automatically, may be used fordetecting one or more analytes in small body fluid samples. Thus,generally, the chamber, the puncture element, the housing and,optionally, the test chemical may be setup internally as known in theart, such as disclosed in WO 2012/089524 A1 and/or as in WO 2012/140027A1, wherein the latter specifically discloses single tests.Additionally, the present invention provides a compression elementwhich, generally, may be embodied as an element which is independentfrom the housing of the sampling element. The compression element ismovably mounted to the housing, and, thus, the housing and thecompression element form one unit of the sampling element, which may bea disposable sampling element. Simultaneously, the compression elementmay fulfill the function of indicating an unused state or a used stateof the sampling element. Thus, the compression elements may take overthe function of the separate locking mechanism as disclosed e.g. in EP 1459 683 A1 indicating whether the sampling element has been used or not.Consequently, within the present invention of the sampling element, twoelements may be combined in an advantageous fashion, i.e. thecompression element for pressing body fluid from the region ofpuncturing and the locking element adapted to prevent a reuse of a usedsampling element.

Further, the sampling element may provide a test chemical, preferably atest field. For optical measurements by using an optical detector, inmany cases, it is crucial to keep the test field in a fixed positionduring measurements. Thus, the test field, during measurement, shall notmove in order to avoid movement-induced falsifications of themeasurement. When using test element magazines with a large area and alarge mass, with compression elements mounted to the device rather thanto the magazine, this condition typically is rather simple to achieve.Thus, the compression element typically acts on the housing of theanalytical device only, separated from the magazine. Contrarily, insingle tests or single sampling elements, including one single punctureelement and one single test field, the small mass and the smalldimensions of the sampling element typically require the compressionelement to be mounted elsewhere, in order to avoid mechanical influencewhich might move the test field during measurement, thereby disturbingthe optical measurement. Still, the general idea of mounting thecompression element to the housing in a movable fashion, as proposedwithin the present invention, provides the possibility of keeping thehousing with the optional test chemical contained therein in a fixedposition during sampling and measurement, whereas the movablecompression element may move relative to the analytical device and thehousing. Thus, the analytical device may comprise a mounting or lockingmechanism for keeping the housing in place, whereas the compressionelement may move from the first position to the second position. Asufficient amount of clearance between the unlocked compression elementand the housing may allow for the analytical device to take over theguiding of the compression element from the sampling element.Consequently, the compression and/or the triggering, by using thecompression element, may be mechanically independent from the actualmeasurement.

As for the analytical device, the present invention provides optionalmeans for combining an unlocking of the locking mechanism of thecompression element with a driving of the puncture element, in a rathersimple fashion. Thus, as outlined above, a release element and acoupling element may be used, wherein, as an example, the releaseelement may be adapted to deform mounting arms of the compressionelement. The mounting arms preferably provide elastic properties. Thus,as an example, the mounting arms may fully or partially be made of aplastic material, and, thus, may flexibly be deformed by the releaseelement, such as by spreading or forcing apart the mounting arms.Consequently, by using the at least one release element, the lockingmechanism may be unlocked without exerting mechanical influence onto thehousing and, thus, without exerting mechanical influence onto theoptional test field. Thus, by using the release element and the couplingelement, as proposed within the present invention, the decoupling andunlocking of the compression element may mechanically be separated fromthe driving of the puncture element. Further, the compression elementmay be used as a triggering actuator for triggering the puncture motion,without mechanically moving or shocking the actual chamber within thehousing.

Still, the coupling element and the release element, as outlined aboveand as outlined in further detail below, may be driven by a linkmechanism. The link mechanism may as well provide a timing of areleasing action and a coupling action and a puncture action. Thus,generally, a simple actuation mechanism, including an unlocking of thecompression element's locking mechanism, may be provided.

Summarizing, within the present invention, the following embodiments arepreferred:

EMBODIMENT 1

A sampling element for generating a sample of a body fluid, the samplingelement having a housing comprising a chamber with at least one punctureelement stored therein, wherein a tip of the puncture element is movablethrough at least one puncture opening of the housing in order toperforate a skin portion of a user, the sampling element furthercomprising at least one compression element, wherein the compressionelement preferably at least partially surrounds the puncture opening,wherein the compression element is adapted to increase a pressure of thebody fluid within a body tissue of the user in a region of puncturingwhen pressed onto the skin portion of the user, wherein the compressionelement is movably mounted to the housing, wherein the sampling elementcomprises at least one locking mechanism for releasably locking thecompression element in at least two positions, the at least twopositions comprising a first position and a second position, the secondposition being offset from the first position.

EMBODIMENT 2

The sampling element according to the preceding embodiment, wherein thesecond position is offset from the first position in a longitudinaldirection of the sampling element.

EMBODIMENT 3

The sampling element according to the preceding embodiment, wherein thelongitudinal direction is a direction of a puncture motion, wherein thepuncture motion comprises a forward motion of the tip of the punctureelement in order to perforate the skin portion of the user and abackward motion of the tip in order for the puncture element to berestored within the chamber.

EMBODIMENT 4

The sampling element according to the preceding embodiment, wherein thesecond position is offset from the first position in a direction of thebackward motion.

EMBODIMENT 5

The sampling element according to any of the preceding embodiments,wherein the compression element is linearly movable with regard to thehousing.

EMBODIMENT 6

The sampling element according to any of the preceding embodiments,wherein the compression element comprises at least one trigger portionadapted to exert a trigger action onto a trigger of an analytical deviceusing the sampling element when the compression element is moved fromthe first position into the second position.

EMBODIMENT 7

The sampling element according to the preceding embodiment, wherein thetrigger portion comprises an edge of the compression element, preferablyan edge of a mounting portion of the compression element and morepreferably an edge of at least one mounting arm of the compressionelement.

EMBODIMENT 8

The sampling element according to any of the preceding embodiments,wherein the compression element is movably mounted to the housing suchthat, when the locking mechanism is released and when the compressionelement is pressed onto the skin portion of the user, the compressionelement is moved from the first position into the second position.

EMBODIMENT 9

The sampling element according to any of the preceding embodiments,wherein the compression element comprises at least one annularprotrusion being adapted to be pressed onto the skin portion in theregion of puncturing, the compression element further having a mountingportion movably mounted to the housing.

EMBODIMENT 10

The sampling element according to the preceding embodiment, wherein themounting portion comprises at least one mounting arm which is slidablyguided in a guiding of the housing.

EMBODIMENT 11

The sampling element according to the preceding embodiment, wherein theguiding comprises at least one guide rail.

EMBODIMENT 12

The sampling element according to any of the two preceding embodiments,wherein the mounting arm is a snap arm adapted to snap into at least onecorresponding notch in the first position and the second position.

EMBODIMENT 13

The sampling element according to any of the preceding embodiments,wherein the housing comprises at least one guiding, preferably at leastone guide rail, wherein the compression element slidably is mounted tothe guiding.

EMBODIMENT 14

The sampling element according to the preceding embodiment, wherein theguiding extends along a longitudinal axis of the sampling element.

EMBODIMENT 15

The sampling element according to any of the preceding embodiments,wherein the locking mechanism comprises a releasable snap fitconnection.

EMBODIMENT 16

The sampling element according to any of the preceding embodiments,wherein the compression element comprises at least one snap arm which isadapted to releasably snap into a first notch when the compressionelement is in the first position and to snap into a second notch whenthe compression element is in the second position.

EMBODIMENT 17

The sampling element according to any of the preceding embodiments,wherein at least one of the at least two positions functions as anindication whether the sampling element has been used or not.

EMBODIMENT 18

The sampling element according to any of the preceding embodiments,wherein the sampling element is a disposable sampling element adaptedfor single use, wherein the first position is an unused position andwherein the second position is a used position.

EMBODIMENT 19

The sampling element according to any of the preceding embodiments,wherein at least a part of the compression element protrudes from thehousing and forms a protrusion from the sampling element when thecompression element is in the second position.

EMBODIMENT 20

The sampling element according to any of the preceding embodiments,wherein the puncture element comprises at least one capillary adapted toreceive body fluid from the region of puncturing.

EMBODIMENT 21

The sampling element according to the preceding embodiment, wherein thepuncture element is a micro-sampler having at least one capillary slot.

EMBODIMENT 22

The sampling element according to any of the preceding embodiments,wherein the sampling element further comprises at least one testchemical adapted for performing at least one detectable detectionreaction in the presence of at least one analyte to be detected, whereinthe sampling element is adapted to transfer body fluid onto the testchemical.

EMBODIMENT 23

The sampling element according to the preceding embodiment, wherein thetest chemical is comprised in at least one test field.

EMBODIMENT 24

The sampling element according to any of the two preceding embodiments,wherein the test chemical is accessible from the chamber.

EMBODIMENT 25

The sampling element according to the preceding embodiment, wherein thesampling element is adapted to take up the sample of the body fluid withthe puncture element in a puncture motion of the puncture element and totransfer the sample of the body fluid from the puncture element onto thetest chemical.

EMBODIMENT 26

The sampling element according to the preceding embodiment, wherein thesampling element is adapted to bring the puncture element close to thetest chemical when the puncture element is pulled back into the chamber.

EMBODIMENT 27

The sampling element according to any of the preceding embodiments,wherein the housing further comprises at least one actuator openingadapted for a coupling element to enter the chamber and to engage withthe puncture element in order to drive the puncture element for apuncture motion.

EMBODIMENT 28

The sampling element according to any of the preceding embodiments,wherein the puncture element comprises at least one connection elementadapted to engage with at least one coupling element for being driven toperform a puncture motion.

EMBODIMENT 29

The sampling element according to the preceding embodiment, wherein theconnection element comprises at least one opening adapted to be engagedby a hook of the coupling element.

EMBODIMENT 30

The sampling element according to any of the preceding embodiments,wherein the sampling element contains precisely one puncture element.

EMBODIMENT 31

An analytical device, the analytical device being adapted for using thesampling element according to any of the preceding embodiments, theanalytical device comprising at least one coupling element adapted fordriving the puncture element to perform a puncture motion, theanalytical device further comprising at least one release element, therelease element being adapted for releasing the locking mechanism of thesampling element in the first position before performing the puncturemotion in order to allow for the compression element of the samplingelement to be moved from the first position into the second position.

EMBODIMENT 32

The analytical device according to the preceding embodiment, wherein thecoupling element comprises at least one hook adapted to engage with anopening of the puncture element of the sampling element.

EMBODIMENT 33

The analytical device according to any of the two preceding embodiments,wherein the release element comprises at least one release element baradapted to be pushed in between at least a part of the compressionelement and the housing of the sampling element in order to release thelocking mechanism.

EMBODIMENT 34

The analytical device according to the preceding embodiment, wherein theat least one release element bar comprises a wedge.

EMBODIMENT 35

The analytical device according to any of the preceding embodimentsreferring to an analytical device, wherein the coupling element and therelease element are driven via a link mechanism, preferably by twodrives acting on a link mechanism which transmits the movements of thetwo drives onto the coupling element and the release element in a jointmanner.

EMBODIMENT 36

The analytical device according to the preceding embodiment, wherein thelink mechanism comprises at least one lever connected both to thecoupling element and the release element.

EMBODIMENT 37

The analytical device according to any of the preceding embodimentsreferring to an analytical device, wherein the coupling element and therelease element are mounted on a common guide, such as a common linearguide, and, preferably, are independently movable on the guide.

EMBODIMENT 38

The analytical device according to any of the preceding embodimentsreferring to an analytical device, wherein the release element isspring-biased in order to reengage the locking mechanism aftertriggering the sampling action.

EMBODIMENT 39

The analytical device according to any of the preceding embodimentsreferring to an analytical device, wherein the analytical device furthercomprises at least one trigger adapted to initiate the coupling elementto drive the puncture motion, wherein the trigger is adapted to beactuated by the compression element when the compression element ismoved from the first position into the second position.

EMBODIMENT 40

The analytical device according to any of the preceding embodimentsreferring to an analytical device, wherein the analytical device isfurther adapted to prevent the coupling element to drive the puncturemotion when the compression element is found to be in the secondposition, thereby preventing a reuse of a used sampling element.

EMBODIMENT 41

The analytical device according to any of the preceding embodimentsreferring to an analytical device, wherein the analytical device isfurther adapted to prevent the sampling element to be located in anapplication position of the analytical device when the compressionelement is found to be in the second position, thereby preventing areuse of a used sampling element.

EMBODIMENT 42

The analytical device according to any of the preceding embodimentsreferring to an analytical device, wherein the analytical device furthercomprises at least one sampling element according to any of thepreceding embodiments referring to a sampling element.

EMBODIMENT 43

The analytical device according to the preceding embodiments, whereinthe analytical device comprises a plurality of the sampling elements.

EMBODIMENT 44

The analytical device according to any of the preceding embodimentsreferring to an analytical device, wherein the analytical devicecomprises an application position, wherein the analytical device isadapted to subsequently move sampling elements into the applicationposition and to perform a puncture motion by using the sampling elementin the application position.

EMBODIMENT 45

The analytical device according to any of the preceding embodimentsreferring to an analytical device, wherein the analytical device furthercomprises at least one detector adapted to detect at least one detectionreaction of a test chemical of the sampling element.

EMBODIMENT 46

The analytical device according to the preceding embodiment, wherein thedetector is an optical detector adapted to detect an opticallydetectable detection reaction of the test chemical.

EMBODIMENT 47

The analytical device according to the preceding embodiment, wherein theoptical detector comprises at least one light source adapted toilluminate the test chemical of the sampling element.

EMBODIMENT 48

The analytical device according to the preceding embodiment, wherein theoptical detector comprises at least one light source adapted toilluminate the test chemical of the sampling element.

EMBODIMENT 49

The analytical device according to any of the two preceding embodiments,wherein the optical detector comprises at least one light-sensitiveelement adapted to detect light propagating from the test chemical tothe detector.

EMBODIMENT 50

The analytical device according to any of the four precedingembodiments, wherein the analytical device is adapted to perform thefollowing steps:

a) releasing the locking mechanism by using the release element;

b) driving the puncture element to perform a puncture motion by usingthe coupling element, thereby generating the sample of the body fluid;

c) at least partially transferring the sample of the body fluid onto thetest chemical; and

d) detecting the detection reaction by using the detector.

EMBODIMENT 51

The analytical device according to the preceding embodiment, wherein theanalytical device is further adapted to perform the following step:

e) determining a concentration of at least one analyte in the body fluidby evaluating at least one signal generated by the detector.

EMBODIMENT 52

A method of generating a sample of a body fluid, the method comprising ause of the analytical device according to any of the precedingembodiments referring to an analytical device, the method comprising thefollowing steps:

i) releasing the locking mechanism by using the release element;

ii) driving the puncture element to perform a puncture motion by usingthe coupling element, thereby generating the sample of the body fluid.

EMBODIMENT 53

A use of a position of a compression element adapted to increase apressure of a body fluid within a body tissue of a user in a region ofpuncturing, the compression element being movably mounted to a housingof a sampling element, for indicating a used or unused state of thesampling element for preventing reuse of the sampling element.

SHORT DESCRIPTION OF THE FIGURES

Further optional features and embodiments of the invention will bedisclosed in more detail in the subsequent description of preferredembodiments, preferably in conjunction with the dependent claims.Therein, the respective optional features may be realized in an isolatedfashion as well as in any arbitrary feasible combination, as the skilledperson will realize. The scope of the invention is not restricted by thepreferred embodiments. The embodiments are schematically depicted in theFigures. Therein, identical reference numbers in these Figures refer toidentical or functionally comparable elements.

In the figures:

FIG. 1 shows a perspective view of a sampling element;

FIG. 2 shows a cross-sectional view along a longitudinal axis of thesampling element of FIG. 1;

FIG. 3 shows a perspective view of a housing of the sampling element ofFIG. 1;

FIG. 4 shows a perspective view of a compression element of the samplingelement of FIG. 1;

FIG. 5 shows a top view of a sampling element with the compressionelement in a first position;

FIG. 6 shows a cross-sectional view of the sampling element of FIG. 1 ina plane perpendicular to a longitudinal axis;

FIG. 7 shows a top view of the sampling element with a locking mechanismunlocked, the compression element still in the first position;

FIG. 8 shows a cross-sectional view of the setup of FIG. 7, with arelease actuator forcing apart the mounting arms of the compressionelement;

FIG. 9 shows a top view of the sampling element, with the compressionelement in the second position and the locking mechanism still unlocked;

FIG. 10 shows a cross-sectional view of FIG. 9, with the releaseactuator still in place;

FIG. 11 shows a top view of the sampling element, with the compressionelement in the second position and the locking mechanism locked;

FIG. 12 shows a cross-sectional view of the setup of FIG. 11, with therelease actuator removed;

FIG. 13 shows a setup of an analytical device with the sampling elementof FIG. 1, in an initial position;

FIG. 14 shows the analytical device of FIG. 13 in a preparation movementfor releasing the locking mechanism of the sampling element;

FIG. 15 shows the analytical device performing a puncture motion; and

FIGS. 16A-16C show a sequence of motions of a link mechanism of theanalytical device performing a preparation motion and a puncture motion.

DETAILED DESCRIPTION OF THE EMBODIMENTS

In FIGS. 1-12, various views of an embodiment of a sampling element 110for generating and, in this case, optionally analyzing a sample of abody fluid are depicted. The analysis, in this case, as an example, maybe adapted for determining the concentration of one or more analytescontained within the sample of the body fluid, such as glucose withinblood and/or interstitial fluid. In the following, when explaining thesetup and the functions of the sampling element, reference will be madeto FIGS. 1-12 in conjunction.

In FIG. 1, a perspective view of the sampling element 110 is given. Thesampling element 110 is a single sampling element, adapted for a singleuse, i.e. a single test containing precisely one puncture element 112,as will be explained with regard to FIG. 2 below. The sampling elementcomprises a housing 114, which, as an example, may be made of a plasticmaterial, such as by injection molding. As an example, the housing 114may be composed of one or more parts, such as an upper housing part 116and a lower housing part 118. The housing, as can be seen in across-sectional view along a longitudinal axis 120 in FIG. 2, which maybe an axis of the puncture motion and/or an axis of a longitudinalextension of the puncture element 112, contains a chamber 122,preferably a single chamber 122.

Within the chamber 122, the puncture element 112 is stored. The chamber122 comprises a puncture opening 124 at a front face 126 of the housing114 and an actuator opening 128 at a rear face 130. Through the actuatoropening 128, a coupling element, which will be explained in furtherdetail below, may enter the chamber 122, engage with the punctureelement 112, and drive a tip 132 of the puncture element to exit thepuncture opening 124 in a forward direction 134, in order to perforate askin portion of a user in a region of puncturing. Afterwards,preferably, the coupling element may retract the tip 132 into thechamber 122 in a rearward direction 136, in order to safely restore thepuncture element 112 within the chamber 122.

Further, during the rearward movement, body fluid taken up by thepuncture element 112, which preferably may comprise one or morecapillary elements, such as one or more open capillary slits, may betransferred onto a test field 138 having at least one test chemicalcontained therein. The test field 138 is accessible from the interior ofthe chamber 122 in order to allow for a transfer of the sample fluidfrom the puncture element 112 onto the test field 138. As an example,the test field 138 may cover an interior portion of a detector opening142 which may form a window within the housing 114, thereby allowing fora detector 144 (symbolically depicted in FIG. 2), which may be part ofan analytical device, to illuminate the test field by a light source 146and to detect light propagating from the test field 138 to the detector144 by using at least one light-sensitive element 148. For furtherpotential details of the setup of the chamber 122 and the test field138, as an example, reference may be made to the setup disclosed in WO2012/140027 A1 and/or the setup disclosed in WO 2012/089524 A1. Still,other embodiments are feasible.

The sampling element 110 further comprises a compression element 150which is adapted to increase a pressure of the body fluid within a bodytissue of the user in a region of puncturing when pressed onto the skinportion of the user. Thus, as an example, a point in which thelongitudinal axis 120 hits the skin portion of the user when thesampling element is pressed onto the skin portion may determine a regionof puncturing, i.e. a region in which the tip 132 perforates the skinportion, thereby creating a puncture opening. The compression element150 may comprise an annular protrusion 152 which, preferably, forms arim of a compression opening 154 within the compression element 150.

The compression element 150 preferably at least partially surrounds thepuncture opening 124. As used herein, the compression element 150 atleast partially surrounding the puncture opening 124 is to be understoodthat, when projected onto a common plane perpendicular to thelongitudinal axis 120, the puncture opening 124 at least partially isvisible through the compression element 150, such as through thecompression opening 154. Then pressed onto the skin portion of the user,the compression element 150, specifically the annular protrusion 152,forms a convulsion of the skin portion which extends into thecompression opening 154 and in which a pressure of the body fluid isincreased as compared to body tissue outside the annular protrusion 152.This convulsion may be reached by the tip 132, since the compressionelement 150 fully or partially surrounds the puncture opening 124 and,thus, the convulsion is located in front of the puncture opening 124.Thus, by creating an increased pressure within this region, body fluidis expressed from a puncture opening created by the tip 132 within theskin portion.

As will be explained in further detail with regard to FIGS. 3 and 4below, the housing 114 and the compression element 150 are separateelements which may be manufactured independently. Thus, as outlinedabove, the housing 114 may be made of separate pieces, such as an upperhousing part 116 and a lower housing part 118. The compression element150 may comprise the annular protrusion 152, preferably at an edge ofthe compression of the compression opening 154. The annular protrusionmay act as a compression ring and may be located in a body 156 of thecompression element 150. The body 156 may fully or partially cover thefront face 126 of the housing 114.

The compression element 150, preferably the body 156, is movably mountedto the housing 114, preferably linearly movable with regard to thehousing 114, most preferably in the direction of the longitudinal axis120. For this purpose, the compression element 150 may comprise amounting portion 158 which, in this embodiment, may comprise two or moremounting arms 160. The mounting arms 160 preferably, in this embodimentor in other embodiments, are flexible mounting arms 160. The mountingarms 160 may be guided in an appropriate guiding 162 of the housing 114,which, as an example, may comprise guide rails 164 which are adapted toreceive the mounting arms 160. The guide rails 164 preferably compriselongitudinal grooves extending along side faces 166 of the housing 114,preferably at least essentially parallel to the longitudinal axis 120,i.e. preferably parallel with a tolerance of no more than 20°, morepreferably of no more than 10° and most preferably of no more than 5°.

The sampling element 110 further comprises a locking mechanism 168 whichallows for releasably locking the compression element 150 in at leasttwo positions, the at least two positions comprising a first position170 and a second position 172. The locking mechanism 168 comprises, inthis embodiment, components of the mounting portion 158 of thecompression element 150 and components of the housing 114. Thus, in thisembodiment, the mounting arms 160 are designed as flexible snap arms 174having snap hooks 176 and/or protrusions 178 which may snap intocorresponding elements of the housing 114. Thus, the housing maycomprise first notches 180 in the first position 170 and second notches182 in the second position 172, into which the snap arms 174 may lock.Thus, the snap arms 174 may be locked in the two positions 170, 172. Thesnap arms 174, the snap hooks 176, the protrusions 178 and the first andsecond notches 180, 182 thus all form part of the locking mechanism 168.In order to release the locking mechanism 168 and bring the lockingmechanism into an unlocked state, the snap arms 174 may be forced apart,and, thus, the protrusions 178 may be forced out of the correspondingnotches 180, 182. When released, the compression element 150 may freelymove from the first position 170 into the second position 172, such aswhen a force is exerted onto the annular protrusion 152, by pressing thebody 156 of the compression element 150 onto the skin portion of theuser.

In FIG. 5, a top view of the sampling element 110 is shown, with thelocking mechanism 168 locked and the compression element 150 being inthe first position 170. In this position, as can be seen, the snap arms174 and the protrusions 178 are locked in the first notches 180, on bothsides of the housing 114.

As will be outlined in further detail below, a rear part of the mountingportion 158, in this embodiment a rear part of the mounting arms 160,forms a trigger portion 184 and, in a used state, protrudes from thesampling element 110. As can be seen in FIG. 5, this is not the casewhen the compression element 150 is in the first position. Thus, in thefirst position, preferably, the snap arms 174 do not protrude from thehousing 114. Similarly, in FIG. 6, a cross-sectional view perpendicularto the longitudinal axis of extension is shown, in a direction of viewof the forward direction 134. As can be seen in these figures, the snaparms 174 do not protrude from the housing 114 in a lateral directionwhen the snap arms 174 are locked in this first position.

Still, as can also be seen in FIG. 6, preferably, the guiding 162 isdesigned such that the mounting arms 160 are guided with a clearance186. Thus, when the locking mechanism 168 is released, preferably, thecompression element 150 may move freely from the housing 114, withclearance in all spatial dimensions. Thus, due to this clearance, amovement of the compression element 150 relative to the housing 114 doesnot imply any mechanical influence exerted onto the housing 114 and,thus, does not disturb an optical measurement. Most preferably, duringthat movement, the compression element 150 and the housing 114 do nottouch or, at least, have a minimum contact, such as in the region of thesnap hooks 176, only.

For preparing a measurement, as will be outlined in further detailbelow, the sampling element 110 is docked to an analytical device andthen the mounting arms 160, which preferably are elastic or flexiblemounting arms 160, are forced apart such that the compression element150 does not provide any significant contact to the housing 114 anylonger. This is shown in FIGS. 7 and 8. Thus, FIG. 7 shows the samplingelement, as in FIG. 5, with the mounting arms 160 forced apart. Byforcing apart these mounting arms 160, the snap hooks 176 and theprotrusions 178 are unlocked from the first notch 180, and the lockingmechanism is unlocked. In FIG. 7, a cross-sectional view in a planeparallel to the longitudinal axis 120 is shown which indicates that thisforcing apart of the mounting arms 160 may take place by one or moreappropriate release elements 188 having release element bars 190 withwedges 192 at their front ends, which glide along gliding surfaces 194of the snap hooks 176, when pushed in the forward direction 134.

The release element bars 190, preferably, are fully or partially made ofa less flexible material, such as a metal. Thus, by spreading apart themounting arms 160, the clearance 186 is increased, the locking mechanism168 is unlocked, and, thus, the compression element 150 is freelymovable in a direction parallel to the longitudinal axis 120, withoutmechanically affecting the housing 114 with the chamber 122 disposedtherein. This avoidance of mechanical influences may be essential formeasurement, since, typically, in optical measurements, at least twomeasurement values have to be taken at two different points in time, onebefore the test field 138 is wetted by the body fluid (dry value) and atleast one after wetting. Most preferably, the test field 138, in betweenthese at least two measurements, shall not move relative to the detector144, in order to avoid falsifications of the measurement.

Thus, as can be seen in FIG. 8, the locking mechanism 168 allows for amechanical simple unlocking by the release element 188. In the unlockedstate, the protrusions 178 of the snap hooks 176 are lifted from thefirst notch 180 and, thus, the compression element 150 may move in arearward direction 136, from the first position 170 to the secondposition 172. This movement of the compression element 150 from thefirst position 170 into the second position 172 in the rearwarddirection 136 may, as an example, be driven by pushing the compressionelement 150, specifically the annular protrusion 152, onto the skinportion of the user, thereby pushing the compression element 150 intothe rearward direction 136 and, simultaneously, increasing the pressurein the body tissue of the user in the region of puncturing. The latterprocess is also referred to as “milking”.

In FIGS. 9 and 10, in view similar to FIGS. 7 and 8, respectively, theprocess of the rearward movement of the compression element 150 isshown. As can be seen, during this movement, the mounting arms 160 arespread apart and, thus, the rearward ends 196 protrude from the housing114 and form trigger portions 184. These trigger portions 184 mayinteract with a trigger 198 of an analytical device, such as a simpletrigger 198 shown in the cross-sectional view of FIG. 10. As soon as therearward end 196, which protrudes from the housing 114, hits the trigger198, a puncture motion may be triggered. The trigger 198, which is shownin a simplified schematic view, may comprise any type of triggermechanism known to the skilled person in the art of puncture elements.The trigger 198 may be made with a minimum trigger force which is givenin any case when the compression element 150 is pressed onto the skinsurface of a user, such that the triggering force if provided in anyevent of use. This trigger force at the same time may be the milkingforce which is necessary for expressing bodily fluid from the puncturedskin. Thus, the compression element 150 simultaneously acts as a part ofa trigger mechanism of the analytical device. By the triggering process,the annular protrusion 152 of the compression element 150 is pushed backinto a position adapted for an appropriate puncture depth. This secondposition 172 may either be a fixed position or an adaptable position.Still, preferably, no mechanical force is exerted onto the housing 114during the movement of the compression element 150, in order to avoiddisturbances of the detection.

In FIGS. 11 and 12, in a view similar to the views given in FIGS. 7 and8 or 9 and 10, respectively, a state of the sampling element 110 afterthe measurement is shown, which is a used state of the sampling element110. In this state, the release actuator 188 has been withdrawn from thesampling element 110, and the mounting arms 160 are not spread apart anylonger. The locking mechanism, again, is in a locked state, with thecompression element 150 being in the second position 172. In this secondposition 172, the snap hooks 176, with their protrusions 178, snap intothe second notches 182. However, as specifically may be seen in thecross-sectional view of FIG. 12, the rearward ends 196 of the mountingarms 160 protrude from the housing 114, forming a protrusion 200indicating a used state of the sampling element 110. This is due to thefact that, as an example, a depth d₂ of the second notches 182 may besmaller than a depth d₁ of the first notches 180.

The protrusions 200 may be used in various ways. Thus, the protrusions200 may simply indicate to a user that the sampling element 110 is aused sampling element and, thus, may indicate that a reuse shall beavoided. Additionally or alternatively, the protrusions 200 may be usedfor indicating the used state of the sampling elements 110 to ananalytical device and/or in order to prevent a reuse of the samplingelements 110 in various ways. Thus, as an example, the analytical devicemay provide an appropriate transfer mechanism and/or may provide anappropriate receiving structure which, such as by abutting theprotrusions 200, may mechanically prevent a used sampling element 110from being brought into an application position within the analyticaldevice. Thus, as an example, the analytical device may provide elasticblocking elements, similar to a fish trap, which allow for a usedassembling element 110 to be removed from an application position of theanalytical device but which prevents the used assembling element 110 tobe returned into the application position. This simple blockingmechanism 202, which allows for removing the sampling element 110 froman analytical device in the forward direction 134 and, by abutting theprotrusions 200 when attempting pushing back the used sampling element110 in the rearward direction 136, is indicated symbolically in FIG. 12.

In FIGS. 13 through 16C, various views of an embodiment of an analyticaldevice 204 are shown, which make use of the sampling element 110 asdisclosed in FIGS. 1-12 above. The sampling element 110 may be part ofthe analytical device 204 or may be introduced into the analyticaldevice 204 as an independent element. Further, one or more of thedetector 144 as shown in FIG. 2, the trigger 198 as shown in FIG. 10 orthe blocking mechanism 202 as shown in FIG. 12 may be part of theanalytical device 204, too. The analytical device 204 may furthercomprise a housing, which is not shown in the figures. In FIGS. 13-15,the analytical device 204 is shown in various actuation states, whereasFIGS. 16A-16C, in a combined sequence of the images of FIGS. 13-15, showa complete sampling cycle. In the following, reference will be made toall of these figures.

The analytical device 204 comprises two types of actuators orinteracting elements, which is at least one coupling element 206 and therelease element 188. As outlined above, the release element 188, havingthe release element bars 190, is adapted for releasing the lockingmechanism 168 of the sampling element 190. The coupling element 206 onthe other hand is adapted to drive the puncture element 112 to perform apuncture motion. For the latter purpose, the coupling element maycomprise one or more hooks 208 adapted for engaging with an appropriateopening 210 at a rearward end of the puncture element 112 (see FIG. 2).Thus, the coupling element 206 is adapted to enter through the actuatoropening 128 of the housing 114, to engage with the puncture element 112,to drive the puncture element 112 to perform a puncture motion in theforward direction 134, thereby perforating a skin portion of the user,and, afterwards, retracting the puncture element 112 into the chamber122, in order to safely restore the puncture element 112 within thechamber 122. For details of this mechanism, as an example, reference maybe made to one or more of documents WO 2011/044971 A2, WO 2012/140027 A1or WO 2012/089524 A1. Still, other types of interaction of the couplingelement 206 with the puncture element 112 are feasible.

The coupling element 206 and the release element 188 may both be mountedmovably in the longitudinal direction 120. Thus, preferably, both thecoupling element 206 and the release element 188 may be mounted on acommon guide 212, such as a linear guide. The guide 212 may compriseslide bars 214 or any other type of guiding. On the slide bars 214, twoindependent slide carriages 216, 218, may be mounted slideably in thelongitudinal direction 120. Thus, a first slide carriage 216 may beprovided, which carries the release elements 188. Further, a secondslide carriage 218 may be provided which carries the coupling element206. The slide bars 214 may be kept in place by one or more mountingelements 220, such as one or more mounting blocks. Thus, even though theactuators 188 or 206 are mounted movably on the same guide 212, they maybe adapted to move independently, preferably linearly, in thelongitudinal direction 120, by the slide carriages 216, 218,independently and parallel, preferably coaxially, moving on the slidebars 214.

The release element 188 and the coupling element 206 may be drivenindependently or, preferably, by using a link mechanism 222, as shown inthe embodiment of FIGS. 13-16C. Thus, as an example, the link mechanism222 may comprise at least one lever 224, the movement of which may becontrolled by a shank 226 and the first slide carriage 216. the shank226 may be coupled to and guided by a drive mechanism of the analyticaldevice 204, such as a drive mechanism having an electrical motor and/ora drive mechanism having one or more spring-based elements, such as oneor more releasable spring mechanisms as generally known in the art. Bythese types of drives, the shank 226 may be adapted to providemovements, which, at least partially, are directed in the forwarddirection 134 and/or the rearward direction 136, thereby pivoting thelever 224.

The lever 224 may be coupled to the release element 188 and the couplingelement 206, preferably in a pivotable fashion. Thus, as can be seen inFIG. 13 and FIG. 16A, the lever 224 may be coupled to the first slidecarriage 216, which is the slide carriage of the release element 188, bya first bearing pin 230 and, further, may be coupled to the second slidecarriage 218, which is the slide carriage of the coupling element 206,by a second bearing pin 232. In order to provide the possibility of anindependent movement of the slide carriages 216, 218, the coupling ofthe bearing pins 230, 232 to the lever 224 shall be such that a distanceof the coupling points may vary. For this purpose, in the embodimentshown in FIG. 13, as an example, the first bearing pin 230 is guided ina further guide slot 234 of the lever 224, which, preferably, may belocated at an opposing end to the end of the lever 224 comprising theguide slot 228. A distance between the shank 226 and the bearing pins230, 232, may determine a lever ratio of the link mechanism 222. Thelever ratio determines the movement of the first slide carriage 216,when the shank 226 and/or the first slide carriage 216 are moved.

In FIGS. 14 and 15, a preparation action (FIG. 14), implying releasingthe locking mechanism 168, and a puncture action (FIG. 15) are shown infurther detail. Thus, firstly, in FIG. 14 and FIG. 16B, a preparationaction is shown, in order to prepare the sampling element 110 forsampling. For this purpose, the first slide carriage 216 is pushedforward. Thereby, as explained with regard to FIGS. 7 and 8 above, therelease element bars 190 are forced in between the housing 114 and themounting arms 160, thereby releasing the locking mechanism 168, asexplained above. The movement of the first slide carriage 216 issimultaneously transmitted to the second slide carriage 218 by the linkmechanism 222, here the lever 224. Thereby, the coupling element 206enters the chamber 122 and engages with the puncture element 112 housedin there. The stagnant shank 226 acts in this preparation phase as apivot axis for the lever 224. At the end of this phase the first slidecarriage 216 is held in place.

Still, as shown in FIG. 14 and FIG. 16B, the compression element 150 isin the first position 170, even though the locking mechanism 168 isunlocked. By pressing the compression element 150, specifically theannular protrusion 152, onto the skin portion of the user, thecompression element 150 is pushed in the rearward direction, and thetrigger portion 184 of one or more of the mounting arms 160 may exert atrigger force onto a trigger 198 (not shown in FIG. 14, see e.g. FIG.10). Thereby, a puncture action is triggered. During the punctureaction, the first slide carriage 216 may maintain the position as shownin FIG. 14 which may keep the release actuator bars 190 forced inbetween the mounting arms 160 and the housing 114, in order to keep thecompression element 150 freely movable with regard to the housing 114,wherein the latter preferably is kept in a fixed application positionwithin the analytical device 204.

The puncture action is shown in FIG. 15 and FIG. 16C. As outlined above,the puncture action may be triggered by the trigger portion 184 of oneor more of the mounting arms 160 when the compression element 150 ispushed into the second position 172, such as by pushing the annularprotrusion 152 onto a skin portion of the user.

In order to perform a puncture motion, the shank 226 momentarily ispushed into the forward direction 134, as shown in FIG. 15 and FIG. 16C,such as by releasing a spring energy storage, such as by releasing adrive spring or any other lancing actuator which is known by one skilledin the art. By lever action, the movement of the shank 226 istransferred onto the second bearing pin 232 that is part of the secondslide carriage 218 on which the coupling element 206 is mounted, which,consequently, is pushed forward, drives the tip 132 to perform apuncture motion, perforating a skin portion of the user. Then shank 226is moved backward by which the tip 132 is retracted form the wound.Finally back in the rearward position shank 226 stands still again andnow acts as a pivot axis for lever 224. Now the slide carriage 216 ispulled back into the rearward direction 136, e.g. it is released fromits forward position and forced backward by a spring element 236, or itis driven by the preparation drive, and the coupling element 206 isretracted out of the housing 114. As outlined above, preferably, thepuncture element 112 comprises one or more capillary elements, such asone or more capillary slits on one or more surfaces of the punctureelement 112. The sample which is taken up by these capillary elementsmay fully or partially be transferred onto the test field 138, and anoptical detection of a detection reaction, by using the detector 144,may take place.

Since the release element 188 is mounted to carriage 216 it alsoretracts and the locking mechanism 168 reengages, now in the secondposition 172.

It shall be noted that the drive mechanism shown in FIGS. 13-16C is onlyone of a plurality of driving mechanisms possible. Thus, other drivingmechanisms may be used which provide both a release actuator 188 and acoupling element 206, in order to release the locking mechanism 168 in apreparation action and in order to drive the actual puncture motion.

LIST OF REFERENCE NUMBERS

-   110 sampling element-   112 puncture element-   114 housing-   116 upper housing part-   118 lower housing part-   120 longitudinal axis-   122 chamber-   124 puncture opening-   126 front face-   128 actuator opening-   130 rear face-   132 tip-   134 forward direction-   136 rearward direction-   138 test field-   140 test chemical-   142 detector opening-   144 detector-   146 light source-   148 light-sensitive element-   150 compression element-   152 annular protrusion-   154 compression opening-   156 body-   158 mounting portion-   160 mounting arm-   162 guiding-   164 guide rail-   166 side face-   168 locking mechanism-   170 first position-   172 second position-   174 snap arm-   176 snap hooks-   178 protrusions-   180 first notch-   182 second notch-   184 trigger portion-   186 clearance-   188 release element-   190 release element bar-   192 wedge-   194 guiding surface-   196 rearward end-   198 trigger-   200 protrusion-   202 blocking mechanism-   204 analytical device-   206 coupling element-   208 hook-   210 opening-   212 guide-   214 slide bar-   216 first slide carriage-   218 second slide carriage-   220 mounting element-   222 link mechanism-   224 lever-   226 shank-   228 guide slot-   230 first bearing pin-   232 second bearing pin-   234 guide slot-   236 biasing spring element

1. An analytical device for generating a sample of a body fluid,comprising: a sampling element comprising a housing comprising a chamberwith at least one puncture element stored therein, wherein a tip of thepuncture element is movable through at least one puncture opening of thehousing in order to perforate a skin portion of a user; at least onecompression element, wherein the compression element is adapted toincrease a pressure of a body fluid within a body tissue of the user ina region of puncturing when pressed onto the skin portion of the user,wherein the compression element comprises a first, ring-shapedprotrusion which fully or partially surrounds the puncture opening ofthe housing and is positioned to contact the skin portion of the user,wherein the compression element is movably mounted to the housing, thecompression element having a first position prior to use of the samplingelement, and a second position after use of the sampling element; asecond protrusion positioned to prevent use of the sampling element whenthe compression element is in the second position; and a lockingmechanism configured for releasably locking the compression element inthe first position and for non-releasably locking the compressionelement in the second position.
 2. The analytical device of claim 1 inwhich the second position is offset from the first position.
 3. Theanalytical device claim 1, wherein the analytical device furthercomprises at least one detector adapted to detect at least one detectionreaction of a test chemical of the sampling element.
 4. The analyticaldevice of claim 1 and further including at least one coupling elementadapted for driving the puncture element to perform a puncture motion.5. The analytical device of claim 4, wherein the analytical devicefurther comprises at least one trigger adapted to initiate the couplingelement to drive the puncture motion, wherein the trigger is adapted tobe actuated by the compression element when the compression element ismoved from the first position into the second position.
 6. Theanalytical device of claim 1 and further comprising at least one releaseelement, the release element being adapted for releasing the lockingmechanism of the sampling element in the first position beforeperforming the puncture motion in order to allow for the compressionelement of the sampling element to be moved from the first position intothe second position.
 7. The analytical device of claim 6, wherein therelease element comprises at least one release element bar adapted to bepushed in between at least a part of the compression element and thehousing of the sampling element in order to release the lockingmechanism.
 8. The analytical device of claim 6 and further including atleast one coupling element adapted for driving the puncture element toperform a puncture motion.
 9. The analytical device of claim 8, whereinthe coupling element and the release element are driven via a linkmechanism.
 10. The analytical device of claim 9, wherein the linkmechanism comprises at least one lever connected both to the couplingelement and the release element.
 11. An analytical device for generatinga sample of a body fluid, comprising: a sampling element comprising ahousing comprising a chamber with at least one puncture element storedtherein, wherein a tip of the puncture element is movable through atleast one puncture opening of the housing in order to perforate a skinportion of a user; at least one compression element, wherein thecompression element is adapted to increase a pressure of a body fluidwithin a body tissue of the user in a region of puncturing when pressedonto the skin portion of the user, wherein the compression elementcomprises a first, ring-shaped protrusion which fully or partiallysurrounds the puncture opening of the housing and is positioned tocontact the skin portion of the user, wherein the compression element ismovably mounted to the housing, the compression element having a firstposition prior to use of the sampling element, and a second positionafter use of the sampling element; a second protrusion positioned toprevent use of the sampling element when the compression element is inthe second position; and the protrusion being positioned to prevent thesampling element from being received within the analytical device whenthe compression element is in the second position.
 12. The analyticaldevice of claim 11 in which the second position is offset from the firstposition.
 13. The analytical device of claim 11 and further including atleast one coupling element adapted for driving the puncture element toperform a puncture motion.
 14. The analytical device of claim 13,wherein the analytical device further comprises at least one triggeradapted to initiate the coupling element to drive the puncture motion,wherein the trigger is adapted to be actuated by the compression elementwhen the compression element is moved from the first position into thesecond position.
 15. The analytical device claim 11, wherein theanalytical device further comprises at least one detector adapted todetect at least one detection reaction of a test chemical of thesampling element.
 16. An analytical device for generating a sample of abody fluid, comprising: a sampling element comprising a housingcomprising a chamber with at least one puncture element stored therein,wherein a tip of the puncture element is movable through at least onepuncture opening of the housing in order to perforate a skin portion ofa user; at least one compression element, wherein the compressionelement is adapted to increase a pressure of a body fluid within a bodytissue of the user in a region of puncturing when pressed onto the skinportion of the user, wherein the compression element comprises a first,ring-shaped protrusion which fully or partially surrounds the punctureopening of the housing and is positioned to contact the skin portion ofthe user, wherein the compression element is movably mounted to thehousing, the compression element having a first position prior to use ofthe sampling element, and a second position after use of the samplingelement; a second protrusion positioned to prevent use of the samplingelement when the compression element is in the second position; and thesampling element being a single-use, disposable sampling element. 17.The analytical device of claim 16 in which the second position is offsetfrom the first position.
 18. The analytical device of claim 16 andfurther including at least one coupling element adapted for driving thepuncture element to perform a puncture motion.
 19. The analytical deviceof claim 18, wherein the analytical device further comprises at leastone trigger adapted to initiate the coupling element to drive thepuncture motion, wherein the trigger is adapted to be actuated by thecompression element when the compression element is moved from the firstposition into the second position.
 20. The analytical device claim 16,wherein the analytical device further comprises at least one detectoradapted to detect at least one detection reaction of a test chemical ofthe sampling element.